Anumana and AliveCor Collaborate to Advance AI for Cardiology

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Bioworld: Anumana Inc. has garnered a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-powered electrocardiogram-based algorithm for early identification of cardiac amyloidosis. The ECG-AI detection algorithm is the fourth from the company and its partners to notch breakthrough status.

Anumana’s AI algorithm for cardiac amyloidosis gets FDA breakthrough nod

Based on pioneering research from Mayo Clinic, ECG-AI LEF aims to aid physicians in identifying low ejection fraction in patients at risk of heart failure

CAMBRIDGE, Mass. – Oct. 2, 2023 – Anumana, Inc., a leading AI-driven health technology and nference portfolio company working in collaboration with Mayo Clinic, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for ECG-AI LEF, a breakthrough artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure.

LEF, or a weak heart pump, is a significant, at times asymptomatic, and commonly undiagnosed indicator of heart failure.1 The increasing prevalence of heart failure and its associated morbidity, mortality, rehospitalizations, and societal costs2,3 underscores the need to identify and manage patients with LEF.

“Anumana’s ECG-AI LEF fills an important unmet need – the lack of an easily accessible point-of-care, noninvasive, and inexpensive tool to screen for a weak heart pump,” said Paul Friedman, M.D., chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minn. and chair of Anumana’s Board of Advisors. “It allows identification of otherwise hidden disease, for which many effective, lifesaving treatments are available – once the presence of the disease is known.”

Developed in partnership with Mayo Clinic, Anumana’s ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to screen for LEF in adults at risk for heart failure using data from a routine 12-lead electrocardiogram (ECG), a rapid and common test used in both primary and specialty care. Based on pioneering research from Mayo Clinic,4 the algorithm has been developed utilizing over 100,000 ECG and echocardiogram data pairs from unique patients and has been clinically tested in more than 25 studies involving more than 40,000 patients in the U.S. and internationally.5

Anumana’s ECG-AI LEF was clinically validated in a multi-site, retrospective clinical study of 16,000 racially diverse patients, achieving its primary endpoint with an 84.5% sensitivity and 83.6% specificity.6 ECG-AI LEF achieved an AUROC7 of 0.932, demonstrating an ability to differentiate between LEF and ejection fraction (EF) >40% extremely well (a score ≥0.90 is considered excellent8) and better than most tests currently used in heart failure standard of care.9

Additionally, the EAGLE study, a groundbreaking prospective, randomized, controlled clinical trial by Mayo Clinic evaluated the use of an investigational version of the algorithm in routine clinical care of 22,641 adults by 120 primary care teams from 45 clinics or hospitals, demonstrating that ECG-AI LEF implementation improved clinician’s ability to diagnosis of LEF by 31% versus standard of care without increasing the overall rate of echocardiogram usage.10

ECG-AI LEF is one of Anumana’s broad pipeline of algorithms, including three additional FDA breakthrough device designation algorithms (pulmonary hypertension, cardiac amyloidosis, and hyperkalemia), and is founded on more than six years of pioneering ECG-AI research and development at Mayo Clinic, including nearly 100 peer-reviewed publications to date.

“Anumana was established in 2021 by nference in partnership with Mayo Clinic to unlock the electrical language of the heart through deep learning and improve disease diagnosis and patient care,” said Murali Aravamudan, co-founder and CEO of Anumana and nference. “In the short time of two years we have secured multiple FDA breakthrough device designations, entered multi-year agreements with three pharma partners, successfully established two new medical procedure codes for ECG AI technology, and now achieved our first FDA breakthrough medical device clearance. This is a significant milestone, and we are excited about the next phase of the journey, deploying our technology in the U.S. and globally to empower clinicians and enhance real-world clinical care.”

Anumana is focused on driving fast-paced adoption of the new ECG-AI category, clinically developing and commercializing its novel technologies in healthcare. The newly FDA-cleared ECG-AI LEF can be easily integrated with various ECG information management systems or directly with a patient’s electronic health record via Anumana’s web-based ECG Viewer to support clinical decision-making.

Anumana spearheaded the effort to bring reimbursement to ECG-AI, receiving approval for two Category III CPT® codes from the American Medical Association in 2022. These codes are now available and designed to facilitate the use, adoption, and potential reimbursement of emerging technologies in clinical workflows.

To learn more about ECG-AI LEF and schedule a demo, visit us at ECG-AI LEF.

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in partnership with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology from an investigational resource to a clinically meaningful tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) solutions aim to detect hidden diseases using ECG-AI algorithms to enhance and improve interventional procedures through real-time AI insights.

Anumana was named one of Fierce MedTech’s Fierce 15 companies for 2022. Follow Anumana at anumana.ai and on LinkedIn and Twitter.

Dr. Friedman and Mayo Clinic have a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.

1.     Jaskanwal D Sara, Takumi Toya, Riad Taher, Amir Lerman, Bernard J Gersh, Nandan S Anavekar. Asymptomatic Left Ventricle Systolic Dysfunction. European Cardiology Review 2020, 15:e13; https://doi.org/10.15420/ecr.2019.14.

2.     Tsao, C.W., Aday, A.W., Almarzooq Z.I., et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. Circulation Vol. 147, No. 8; https://www.ahajournals.org/doi/10.1161/CIR.0000000000001123#d330256e1.

3.     Khazanie P, Allen LA. Systematizing Heart Failure Population Health. Heart Fail Clin. 2020 Oct;16(4):457-466. Doi: 10.1016/j.hfc.2020.06.006. Epub 2020 Jul 21. PMID: 32888640; PMCID: PMC7737815; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737815/.

4.     Attia, Z.I., Kapa, S., Lopez-Jimenez, F. et al. Screening for cardiac contractile dysfunction using an artificial intelligence–enabled electrocardiogram. Nat Med 25, 70–74 (2019); https://doi.org/10.1038/s41591-018-0240-2.

5.     Anumana data on file and published studies.

6.     Anumana data on file (NCT04963218).

7.     Area Under the Receiving Operating Characteristic curve (AUROC) is a performance metric commonly used to evaluate the ability of a model to distinguish between two classes. An AUROC of 0.5 suggests that the model is no better than random and an AUROC of 1.0 indicates a perfect classifier; https://en.wikipedia.org/wiki/Receiver_operating_characteristic.

8.     Muller MP, Tomlinson G, Marrie TJ, Tang P, McGeer A, Low DE, et al. Can routine laboratory tests discriminate between severe acute respiratory syndrome and other causes of community-acquired pneumonia? Clin Infect Dis. 40:1079–86 (2005); https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8831439/.

9.     Such as NT-proBNP, a common blood test used to help identify LEF today with an AUROC of 0.83; Koschack, J., Scherer, M., Lüers, C. et al. Natriuretic peptide vs. clinical information for diagnosis of left ventricular systolic dysfunction in primary care. BMC Fam Pract 9, 14 (2008); https://doi.org/10.1186/1471-2296-9-14h.

10.   Yao, X., Rushlow, D.R., Inselman, J.W. et al. Artificial intelligence–enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial. Nat Med 27, 815–819 (2021); https://doi.org/10.1038/s41591-021-01335-4.

Pazanga Health Communications for Anumana

Anumana Receives U.S. FDA 510(k) Clearance for ECG-AI Algorithm to Detect Low Ejection Fraction

CAMBRIDGE, Mass, June 27, 2024 Anumana, a leading AI-driven health technology company and portfolio company of nference, announced a new study that revealed promising results in support of further development of its investigational pulmonary hypertension (PH) algorithm. The study, “An electrocardiogram-based AI algorithm for early detection of pulmonary hypertension,” which was published in the European Respiratory Journal, determined that the algorithm used in the study can detect PH using routine 12-lead electrocardiogram (ECG) data.

PH is a severe, progressive disease where delayed diagnosis is associated with a higher risk of morbidity and mortality.1-5 Despite an increasing number of available treatments for the disease, diagnostic delays – often of more than two years from symptom onset - are common, due to the non-specific symptoms at presentation.6-9  To address this challenge, Anumana, in collaboration with Mayo Clinic, Vanderbilt University Medical Center (VUMC), and Janssen Research & Development, LLC, a Johnson & Johnson company, has developed an Al algorithm designed to detect PH using routinely collected 12-lead ECG data. 

In the newly published study, a convolutional neural network developed for detecting PH was trained and validated using retrospective ECG and either right heart catheterization or echocardiogram data from 39,823 PH-likely patients and 219,404 control patients from Mayo Clinic. The algorithm used in the study was further validated on an additional 6,045 PH-likely patients and 24,256 control patients from VUMC. The algorithm demonstrated promising performance in identifying PH, achieving an area under the receiver operating characteristic curve (AUC) of 0.92 in the diagnostic test set at Mayo Clinic and 0.88 at VUMC, where AUC values range from 0 to 1.10


The PH algorithm received Breakthrough Device designation from the FDA in 2022, and Anumana is continuing to develop the PH algorithm in pursuit of FDA clearance and CE marking. Anumana has previously received FDA 510(k) clearance for its ECG-AI™ LEF algorithm, which helps clinicians detect low ejection fraction in patients at risk of heart failure.

“The promising data from our study suggest that an AI algorithm has the potential to non-invasively detect PH at an early stage using standard ECGs. This finding marks a significant step forward in the care and management of PH patients who often have a long diagnostic journey,” said Dr. Hilary DuBrock, a Mayo Clinic pulmonologist and lead author of the study. 

“These new data underscore the potential of AI algorithms to empower clinicians to uncover diseases earlier, improve patient outcomes and bring us one step closer to our mission to transform cardiac care,” said Maulik Nanavaty, CEO of Anumana. “We’re continuing to work closely with our partners to further clinically validate this much-needed algorithm, which can help clinicians worldwide get PH patients into treatment sooner to address symptoms and prolong life.” 

Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.


Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.   

Anumana’s lead algorithm, ECG-AI™ LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction earlier and schedule a demo, visit us at ECG-AI LEF.  

schoinski@pazangahealth.com                                    

(860) 301-5058                              


McLaughlin VV et al. .J Am Coll Cardiol 2018; 71(7):7522–763.​

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Vachiéry JL et al. Eur Respir Rev 2012; 21(123):40–47.

Brown LM, Chen H, Halpern S, et al. Delay in recognition of pulmonary arterial hypertension: factors identified from the REVEAL Registry. Chest 2011: 140(1): 19-26.

Didden EM, Lee E, Wyckmans J, et al. Time to diagnosis of pulmonary hypertension and diagnostic burden: A retrospective analysis of nationwide US healthcare data. Pulm Circ 2023: 13(1): e12188.

Armstrong I, Billings C, Kiely DG, et al. The patient experience of pulmonary hypertension: a large cross-sectional study of UK patients. BMC Pulm Med 2019: 19(1): 67.

Maron BA, Humbert M. Finding pulmonary arterial hypertension-switching to offense to mitigate disease burden. JAMA cardiology 2022: 7(4): 369-370.

Hajian-Tilaki, K. Caspian J Intern Med. 2013 Spring; 4(2): 627-635.

Data from Anumana’s New Study Show AI Algorithm Has the Potential to Detect Pulmonary Hypertension Early Using ECG Data

CAMBRIDGE, Mass. – June 25, 2024 – Anumana, a leading AI-driven health technology company and portfolio company of nference, and InfoBionic.Ai, a digital health company specializing in remote cardiac monitoring and diagnostic solutions, today announced a joint research collaboration agreement to develop and commercialize the next generation of remote cardiac care solutions, combining Anumana’s breakthrough ECG-AI™ technology and InfoBionic.Ai’s MoMe ARC® platform. 

By leveraging Anumana's ECG-AI algorithms, developed and validated in collaboration with Mayo Clinic, this initiative aims to enhance InfoBionic.Ai’s MoMe ARC Platform’s ability to detect and intervene in cardiac diseases earlier in the remote patient monitoring setting, with the potential to improve patient outcomes. Anumana and InfoBionic.Ai, both Mayo Clinic portfolio companies,1,2 will continue to work closely with Mayo Clinic under this research agreement.

“It is exciting to see the convergence of our pioneering work in artificial intelligence and remote patient monitoring through this new partnership between Anumana and InfoBionic.Ai,” said Peter Noseworthy, MD, chair of the Heart Rhythm Services Division of Cardiovascular Medicine at Mayo and a board director at InfoBionic.Ai. “By combining InfoBionic.Ai’s remote monitoring solutions with Anumana’s innovative ECG-AI algorithms, including the FDA-cleared algorithm for detecting low ejection fraction (LEF), we aim to equip healthcare providers with the latest cutting-edge tools to detect underlying cardiac conditions earlier, enabling timely intervention and personalized care. It’s a thrilling time for cardiology."

“This collaboration marks an important step in Anumana’s mission to revolutionize cardiac care by enhancing the power of ECG with AI,” said Maulik Nanavaty, CEO of Anumana. “Since the founding of Anumana, our vision has been to elevate the utility of ECG with AI across all the settings in which ECGs are used. By joining forces with InfoBionic.Ai, we are expanding our capabilities from 12 leads in clinical settings to wearable lower-lead ECGs in patients’ homes. We look forward to bringing our AI technology to meet patients and physicians where they are, ultimately benefiting both worldwide.” 

Under the agreement, InfoBionic.Ai and Anumana will develop and integrate Anumana's ECG-AI algorithms, starting with the FDA cleared ECG-AI LEF algorithm, into InfoBionic.Ai's continuous and remote cardiac monitoring platform, allowing the ability to detect LEF and other conditions through the remote monitoring of cardiac activity. The companies will also work together to validate the clinical utility of the integrated solution and seek regulatory clearance to bring this technology to market.

Anumana has received FDA Breakthrough Device Designation for four of its algorithms: low ejection fraction, pulmonary hypertension, cardiac amyloidosis, and hyperkalemia. Its ECG-AI platform won the 2024 MedTech Breakthrough Award for “Best New Technology Solution- Cardiology.” ECG-AI LEF, the company’s FDA-cleared AI algorithm using routine 12-lead ECG data to detect low ejection fraction (LEF), a commonly undiagnosed indicator of heart failure,3 received U.S. FDA clearance in September 2023 and is currently under review in Europe. Anumana has demonstrated that its ECG-AI technology can be adapted to lower-lead ECG devices while maintaining a high degree of performance. A version of the neural network used in Anumana’s FDA cleared ECG-AI LEF algorithm has shown the algorithm to be effective in detecting low ejection fraction using single-lead wearable ECG devices.4 

InfoBionic.Ai’s MoMe ARC is the first and only continuous 6-lead FDA-cleared platform leveraging leading-edge AI analysis and native business intelligence. MoMeARC is a solution that includes a 4-in-1 Gateway device that seamlessly transitions between 2-day in addition to extended Holter tests, Event and MCT modes remotely, streamlining patient monitoring time and minimizing delays.


InfoBionic.Ai’s digital technology has transformed the efficiency and economics of cardiac remote patient monitoring. The company’s vision for its FDA-cleared third-generation platform, the MoMe ARC®, is to remove the roadblocks hindering virtual and remote diagnosis and decision-making. The Massachusetts-based team of seasoned entrepreneurs has had successful careers in healthcare, IT, medical devices, and mobile technology, and brings specific expertise in remote monitoring and cardiology.

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.  

 Anumana’s lead algorithm, ECG-AI™ LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF. 

https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-launches-new-technology-platform-ventures-to-revolutionize-diagnostic-medicine/

https://infobionic.ai/press/infobionic-enters-know-how-agreement-mayo-clinic/

Jaskanwal D Sara, Takumi Toya, Riad Taher, Amir Lerman, Bernard J Gersh, Nandan S Anavekar. Asymptomatic Left Ventricle Systolic Dysfunction. European Cardiology Review 2020, 15:e13; https://doi.org/10.15420/ecr.2019.14.

Attia, Z.I., Harmon, D.M., Dugan, J. et al. Prospective evaluation of smartwatch-enabled detection of left ventricular dysfunction. Nat Med 28, 2497–2503 (2022). https://doi.org/10.1038/s41591-022-02053-1


schoinski@pazangahealth.com                                  

Anumana and InfoBionic.Ai Announce Collaboration to Advance AI-powered Remote Cardiac Telemetry Technology for Early Detection of Cardiac Diseases

CAMBRIDGE, Mass. – October 19, 2023 – Anumana, Inc., a leading AI-driven health technology company and portfolio company of nference, today announced that Maulik Nanavaty has joined Anumana as chief executive officer and member of the Board of Directors. Murali Aravamudan, co-founder of Anumana and nference, has transitioned to executive chairman of the Anumana Board of Directors while continuing as CEO of nference. Nanavaty will lead Anumana through a period of growth as the company begins deploying and commercializing its multi-indication ECG-AI platform technology.

Nanavaty joins Anumana after 18 years at Boston Scientific, where he served as a senior executive with extensive commercial and operational medical device experience in U.S. and international markets. Most recently, Nanavaty was senior vice president and president of Neuromodulation at Boston Scientific, leading the development and commercialization of microelectronic implantable technologies and software used to treat neurological diseases and other chronic conditions. Prior to this role, he served as president of Boston Scientific Japan, and previously vice president and general manager of Interventional Cardiology, Boston Scientific Japan. Prior to Boston Scientific, Nanavaty spent 16 years in various executive positions at Baxter International. 

“It is a delight to announce and welcome Maulik as the new CEO of Anumana on the heels of the recent FDA clearance of our breakthrough ECG-AI LEF device,” said Aravamudan. “Maulik’s decades of experience developing and bringing to market innovative medical products globally is exactly what is needed to build Anumana into a best-in-class multimodal cardiovascular AI enterprise. I am confident his leadership will play a pivotal role in guiding Anumana through its next phase of growth.”

Anumana’s ECG-AI platform represents a breakthrough approach to ECG interpretation, enabling identification of hidden cardiovascular diseases from standard ECGs at the point of care, for which effective, lifesaving treatments may be available. The company’s lead algorithm, ECG-AI LEF, recently received FDA clearance for detecting low ejection fraction, a common undiagnosed indicator of heart failure,1 a prevalent progressive disease that affects over 6 million people in the U.S. and is associated with a significant total annual healthcare cost.2 In addition to the breakthrough ECG-AI LEF, Anumana’s expansive development pipeline includes three additional algorithms with FDA breakthrough designation. The company has multiple ongoing partnerships with leading pharmaceutical companies to further develop and commercialize algorithms in the pipeline.

“Anumana’s mission to unlock the electrical language of the heart in order to improve patient care is incredibly inspiring, and I am grateful for the opportunity to lead its continued progress,” said Nanavaty. “The company has accomplished fast-paced disruptive innovation within just two years since its founding, in close partnership with Mayo Clinic's world-renowned cardiologists and business collaborators. Together, we will build on and accelerate this evidence-based innovative platform, bringing our unique AI-based portfolio of cardiac disease related products to market globally, with real-world evidence in transforming patient outcomes.”

In addition to his role as CEO of Anumana, Nanavaty joins nference as president, Ventures. He will continue to serve as a board member of Rani Therapeutics, a publicly listed biotherapeutics company. Nanavaty earned a Ph.D. in Pharmaceutical Sciences from the University of Illinois and an M.B.A. from the University of Chicago.

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never done before. The company was founded by nference and Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative AI technology applied to ECG, electrophysiology, and hemodynamics, from an investigational resource to a clinically meaningful tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) solutions aim to detect hidden diseases using ECG-AI algorithms to enhance and improve care through real-time AI insights. Anumana SaMDs are designed for real-world physician use, integrating into existing workflows at the point of care to reduce costs and enhance quality of life. Anumana utilizes the nference nSights platform to design, develop, and train new algorithms, and its pipeline of algorithms have been evaluated in retrospective and prospective studies across various institutions both nationally and internationally, including nearly 100 peer-reviewed publications to date. In addition to the company’s first FDA-cleared algorithm, ECG-AI LEF, to detect low left ventricular ejection fraction, three Anumana algorithms (cardiac amyloidosis, pulmonary hypertension, and hyperkalemia) have received FDA Breakthrough Device Designation and are currently undergoing rigorous clinical validation to support additional regulatory submissions.  

Anumana was named one of Fierce MedTech’s Fierce 15 companies for 2022. For more information, visit anumana.ai and follow Anumana on LinkedIn and X (formerly Twitter). 

Through its powerful technology platform and software, nference is transforming healthcare by making biomedical knowledge computable. Its partnerships with major academic medical centers empower nference to synthesize decades of institutional knowledge, producing real-world evidence (RWE) in real time by converting large amounts of de-identified data into deep insights to advance discovery and development of diagnostics and therapeutics. Its proprietary AI-enabled software platform, nSights, harnesses the power of federated learning to accelerate life sciences research, development, and clinical care in significant ways, including biomarker discovery and validation, RWE generation leveraging real-world data, early disease detection, public health policy generation and validation, and more. nference is headquartered in Cambridge, Mass. Follow nference on LinkedIn and Twitter. Visit us at www.nference.com.

1.         Jaskanwal D Sara, Takumi Toya, Riad Taher, Amir Lerman, Bernard J Gersh, Nandan S Anavekar. Asymptomatic Left Ventricle Systolic Dysfunction. European Cardiology Review 2020, 15:e13; https://doi.org/10.15420/ecr.2019.14.

2.         Khazanie P, Allen LA. Systematizing Heart Failure Population Health. Heart Fail Clin. 2020 Oct;16(4):457-466. doi: 10.1016/j.hfc.2020.06.006. Epub 2020 Jul 21. PMID: 32888640; PMCID: PMC7737815; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737815/.

Anumana Appoints Maulik Nanavaty as CEO

Fierce Biotech: Two years after its launch as a joint venture between the Mayo Clinic and Nference to develop artificial intelligence algorithms capable of pulling out new insights from routine electrocardiogram results, Anumana has earned its first 510(k) clearance from the FDA for one of those tools.

Anumana earns first full FDA clearance for AI to detect low ejection fraction

Cardiovascular Business: Anumana, a Massachusetts-based healthcare technology company focused on artificial intelligence (AI), has received a breakthrough device designation from the U.S. Food and Drug Administration (FDA) for a new algorithm designed to identify signs of cardiac amyloidosis in electrocardiograms (ECGs).

FDA grants breakthrough designation for new AI model to detect cardiac amyloidosis in ECG results

WSJ: One project—with the Mayo Clinic and a health-technology company called Anumana based in Cambridge, Mass.—aims to speed up diagnosis of high blood pressure in the lungs, or pulmonary hypertension. It now can take two or more years to identify the life-threatening disease.

J&J Hired Thousands of Data Scientists. Will The Strategy Pay Off?

CAMBRIDGE, Mass. – Dec. 12, 2024 – Anumana, a leading AI-driven health technology company, announced a new collaboration with the American College of Cardiology to join its Innovation Program and accelerate the detection and treatment of cardiovascular disease. 

The collaboration combines Anumana’s expertise in developing AI-based Software-as-a-Medical Device (SaMD) with ACC’s mission to support and transform patient care, bridging the gap between cutting-edge research and the challenges clinicians face in detecting low ejection fraction (LEF). Anumana’s FDA-cleared ECG-AI™ LEF algorithm, which has been included in the CMS 2025 OPPS final rule, effective January 2025, analyzes standard 12-lead electrocardiogram data to identify LEF – a potential early asymptomatic key indicator of heart failure. The ACC Innovation Program and its network of cardiology experts will help Anumana optimize the integration of this algorithm into clinical workflows.

“Joining the ACC Innovation Program provides a unique opportunity to bring Anumana’s state-of-the-art AI technology into closer alignment with clinical practice,” said Maulik Nanavaty, CEO of Anumana. “Collaborating with ACC’s industry experts and leading physicians will help us to further our commitment to developing evidence-based, AI solutions that fit into everyday practice, ultimately improving patient outcomes and addressing the evolving needs of cardiology care.”

The ACC Innovation Program is driving the digital transformation of cardiovascular care by combining research, engagement, and thought leadership. Working with industry experts and academic institutions, the program advances initiatives that improve patient outcomes. ACC aims to search for, aid, and promote the development of technologies that will enable its members to advance the care of their patients.

“Cardiovascular disease remains the leading cause of death worldwide, underscoring the need for innovative solutions that will help physicians detect and manage heart conditions earlier,” said Ami Bhatt, ACC Chief Innovation Officer. “Anumana’s technology offers an opportunity to create a scalable and equitable approach to early disease detection. Together, we’re paving the way for more proactive heart failure management that can improve heart health and deliver tangible benefits to patients.”

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights. Anumana’s award-winning 12-lead algorithm, ECG-AI™ LEF, is now available in the U.S. To learn more about how the algorithm can help clinicians identify LEF earlier and schedule a demo, visit us at ECG-AI LEF. For more information, visit www.anumana.ai or follow us on LinkedIn and X.

The American College of Cardiology (ACC) is the global leader in transforming cardiovascular care and improving heart health for all. As the preeminent source of professional medical education for the entire cardiovascular care team since 1949, ACC credentials cardiovascular professionals in over 140 countries who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. Through its world-renowned family of JACC Journals, NCDR registries, ACC Accreditation Services, global network of Member Sections, CardioSmart patient resources and more, the College is committed to ensuring a world where science, knowledge and innovation optimize patient care and outcomes. Learn more at www.ACC.org or follow @ACCinTouch.

President/CEO, Sampson Public Relations Group

Anumana’s joins ACC to advance AI solutions for detecting heart failure

Anumana Joins the American College of Cardiology to Advance AI-Powered Solutions for Detecting Heart Failure

Anumana’s joins ACC to advance AI solutions for detecting heart failure 

CAMBRIDGE, Mass. – Nov. 14, 2024 – Anumana, a leading AI-driven health technology company, will showcase its leadership in AI-powered cardiovascular solutions at the American Heart Association (AHA) Scientific Sessions 2024, booth #708, in Chicago, and at the North American Primary Care Research Group (NAPCRG) Annual Meeting in Quebec City.

“Empowering physicians with real-time, clinically meaningful insights is at the heart of Anumana’s mission,” said Maulik Nanavaty, CEO of Anumana. “We look forward to showcasing our ECG-AI algorithm, which uses a standard 12-lead ECG to detect low ejection fraction—a key indicator of heart failure. By transforming routine tests into tools that enable earlier diagnosis and treatment, we aim to elevate standards in cardiovascular care and improve patient outcomes.”

At the conferences, Anumana will feature its FDA-cleared ECG-AI™ Low Ejection Fraction (LEF) algorithm, which is currently available in the U.S. and was recently recognized in the CMS 2025 OPPS final rule. The company will also host expert panel discussions to highlight the role of AI in clinical care.

Panel session: “The Future of AI in Cardiology: Trends, Expert Insights, and Panel Discussion”

The session will explore the latest trends of AI/ML devices in cardiology, highlighting the journey of ECG-AI LEF from its initial concept to becoming an FDA-cleared Software as a Medical Device (SaMD). Experts will discuss the opportunities, challenges, and solutions shaping the future of AI in cardiology.

Speakers: Samir Awasthi, MD, PhD; Heather Alger, PhD; Ambarish Pandey, MD; Mark Stampehl, MD

Abstract presentation: “Deep Learning Enabled Electrocardiogram Aimed to Detect Coronary Artery Disease to Predict Atherosclerotic Cardiovascular Events in the Community”

Presentation: November 16 at 10:20-10:25 a.m. CT

“Equity in Equations” Breakfast Symposium: November 17 at 6:30-8:00 a.m. CT

Workshop topic: “Primary Care is the Next Frontier for AI Disruption: Low EF ECG-AI Algorithm Development as a Case Study"

The 90-minute workshop will feature experts who will explore how AI innovations can be integrated into primary care workflows. Topics will cover recent advancements in health technology tools tailored for clinical care, the current state of AI-powered ECG tools, and essential considerations for evaluating and selecting health technology tools for primary care.

Speakers: Heather Alger, PhD, MPH; Rowena Dolor, MD, MHS, MHS; David Rushlow, MD, MBOE; Chris Pullins, MD

Anumana’s ECG-AI platform includes a suite of algorithms designed to help clinicians detect cardiovascular diseases using ECG data. In addition to its FDA-cleared ECG-AI LEF algorithm, Anumana has also received FDA Breakthrough Device Designation for its pulmonary hypertension, cardiac amyloidosis, and hyperkalemia algorithms. The company’s AI tools unlock critical insights from ECGs to enhance the detection and management of heart disease.

About Anumana
Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights. Anumana’s award-winning lead algorithm, ECG-AI™ LEF, is now available in the U.S. To learn more about how the algorithm can help clinicians identify LEF earlier and schedule a demo, visit us at ECG-AI LEF. For more information, visit www.anumana.ai or follow us on LinkedIn and X.

Media Contact
Andrea Sampson
President/CEO, Sampson Public Relations Group
asampson@sampsonprgroup.com

Company to highlight how its ECG-AI™ algorithms enable earlier cardiovascular disease detection

Anumana to Showcase AI-Driven Cardiovascular Solutions at AHA and NAPCRG 2024

CAMBRIDGE, Mass. – May 14, 2024 Anumana, a leading AI-driven health technology company and portfolio company of nference, today announced the appointment of Harry S. Palmin as chief financial officer (CFO). As a veteran in building, financing, and operating life sciences companies, Palmin brings over 25 years of experience to Anumana’s executive leadership team. In his new role, he will lead financial operations, investor relations, and corporate development activities at Anumana, and guide the company’s strategic growth. In addition to his role as CFO of Anumana, Palmin joins nference as CFO, Ventures.

Palmin's distinguished career includes tenure as CFO at Acer Therapeutics Inc., where he played a pivotal role in the company's successful acquisition by Zevra Therapeutics, Inc. His leadership was instrumental in Acer's public offering and the company’s FDA approval for OLPRUVA™, a treatment for urea cycle disorders. Prior to his role at Acer, Palmin served in multiple executive positions at Novelos Therapeutics, Inc., where he helped transform the company from conceptual stage into a leading public oncology and infectious disease development entity. 

“Harry is a highly skilled and accomplished executive with a proven track record in building successful companies in the life sciences industry,” said Maulik Nanavaty, CEO of Anumana. “I am thrilled to welcome Harry to Anumana at an exciting time for the company, where we are making tremendous progress in pipeline development and commercial traction. I look forward to partnering with him through our next phase of growth.” 

Anumana is at the forefront of revolutionizing healthcare with its groundbreaking ECG-AITM platform that, from standard ECGs at the point of care, enables the identification of hidden cardiovascular diseases for which effective, lifesaving treatments may be available. The ECG-AI platform won the 2024 MedTech Breakthrough Award for “Best New Technology Solution- Cardiology.” 

The company’s lead algorithm, ECG-AI LEF, an FDA Breakthrough Device-designated medical device, recently received FDA clearance for detecting low ejection fraction, a common undiagnosed indicator of heart failure1 and prevalent progressive disease that affects over 6 million people in the U.S. and is associated with a significant total annual healthcare cost.2 Anumana’s expansive development pipeline also includes three additional algorithms with FDA Breakthrough Device designation (pulmonary hypertension, cardiac amyloidosis, and hyperkalemia). The company has multiple ongoing partnerships with leading pharmaceutical companies to further develop and commercialize algorithms in its pipeline.3,4 Anumana also spearheaded the effort to bring reimbursement to ECG-AI, receiving approval for two Category III CPT® codes from the American Medical Association in 2022. These codes are now available and designed to facilitate the use, adoption, and potential reimbursement of emerging technologies in clinical workflows.5

“Anumana is one of the most innovative companies in healthcare technology and it is an honor to be joining the organization at such a pivotal time in its growth,” said Palmin. “The progress Anumana has accomplished in just three years since its founding and the potential impact that Anumana’s AI technology platform can make on patient outcomes are inspiring. I am excited to be part of the team and the mission to use pioneering AI technology to unlock the electrical language of the heart and improve patient care.” 

Palmin earned a B.A. in economics and business and an M.A. in international economics and finance from the International Business School at Brandeis University. He also studied at the London School of Economics and the Copenhagen Business School. 

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations, to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect hidden diseases using standard of care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights. 

Anumana’s lead algorithm, ECG-AI™ LEF, is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF. 

Anumana was named one of Fierce MedTech’s Fierce 15 companies for 2022. Follow Anumana at anumana.ai and on LinkedIn and Twitter. 

nference is unlocking the potential of healthcare data with AI, delivering real-world evidence, insights, and solutions informed by the most comprehensive multimodal data across all therapeutic areas. The company’s extensive de-identified, longitudinal data includes decades of clinical notes along with rich patient histories, vitals, lab tests, radiology images, digital pathology, genomics, and electrophysiology waveforms. Our federated data platform, comprising premier healthcare organizations, including Mayo Clinic, Duke Health, Banner Health, Vanderbilt University Medical Center, and Emory Healthcare, enables advanced research and custom AI model development. With unprecedented access to data from over 40 million patient journeys, our partners can accelerate target discovery, optimize clinical trial design, and enhance lifecycle management. Follow nference on LinkedIn. Visit us at www.nference.com.

Khazanie P, Allen LA. Systematizing Heart Failure Population Health. Heart Fail Clin. 2020 Oct;16(4):457-466. doi: 10.1016/j.hfc.2020.06.006. Epub 2020 Jul 21. PMID: 32888640; PMCID: PMC7737815; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737815/.

Anumana and Pfizer Partner to Enable Early Detection of Underdiagnosed Cardiovascular Disease

Anumana Collaborates with Leading Global Health Care Company to Detect Heart Disease Using Artificial Intelligence 

Anumana Announces issuance of New American Medical Association CPT® Category III codes for Novel ECG AI Analysis of Cardiac Dysfunctions

Anumana Appoints Harry S. Palmin as CFO

Anumana’s innovative AI algorithms recognized for their transformative potential in cardiology - the first of which is now commercially available

CAMBRIDGE, Mass. – May 9, 2024 – Anumana, Inc., a leading AI-driven health technology company and portfolio company of nference, announced today it has received the 2024 MedTech Breakthrough Award for Best New Technology Solution in the Cardiology category. The recognition is for Anumana’s suite of artificial intelligence (AI)-based electrocardiogram (ECG) interpretation algorithms, with a spotlight on ECG-AI™ LEF, the company’s FDA cleared, breakthrough AI algorithm using routine 12-lead ECG data to detect Low Ejection Fraction (LEF).

Developed in collaboration with Mayo Clinic, Anumana’s ECG-AI LEF represents a paradigm shift in ECG interpretation. LEF, or a weak heart pump, is a significant, at times asymptomatic, and commonly undiagnosed indicator of heart failure.1 The increasing prevalence of heart failure and its associated morbidity, mortality, rehospitalizations, and societal costs2,3 underscore the need to identify and manage patients with LEF. ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to help clinicians identify LEF in adults earlier by using data from a routine 12-lead ECG, a rapid standard of care test used across primary and specialty care settings. The AI algorithm was clinically validated in a multi-site, retrospective study of 16,000 patients, demonstrating an 84.5% sensitivity and 83.6% specificity.4 Additionally, in a randomized controlled prospective study with 22,641 adults, an investigational version of the algorithm demonstrated the ability to improve primary care clinicians’ diagnoses of LEF by +31% versus standard of care without increasing the overall rate of echocardiogram usage.5  ECG-AI LEF received U.S. FDA clearance in September 2023 and is currently under review in Europe.

Beyond ECG-AI LEF, Anumana has the largest and most robust pipeline of ECG-AI algorithms in development, including three additional FDA Breakthrough Device-designated algorithms (pulmonary hypertension, cardiac amyloidosis, and hyperkalemia), founded on more than six years of pioneering ECG-AI research and development at Mayo Clinic, including nearly 100 studies to date.

“At Anumana, we are committed to developing evidence-based AI algorithms that empower clinicians to uncover diseases earlier and improve patient outcomes,” said Maulik Nanavaty, CEO of Anumana. “We are honored to be recognized by MedTech Breakthrough for our efforts in developing and implementing our cutting edge clinically validated AI algorithms that enhance ECG interpretation. Our ECG-AI algorithm technology represents a groundbreaking shift in the utility of ECG, and we are excited to be at the forefront of improving cardiovascular care with AI technology.”

The MedTech Breakthrough Awards, organized by Tech Breakthrough, an independent, leading market intelligence organization, honors excellence in medical and health related technology, products, services, and people.


ECG-AI LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify LEF earlier and schedule a demo, visit us at ECG-AI LEF.

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful medical-grade and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI solutions aim to detect hidden diseases using standard of care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.

1.     Jaskanwal D Sara, Takumi Toya, Riad Taher, Amir Lerman, Bernard J Gersh, Nandan S Anavekar. Asymptomatic Left Ventricle Systolic Dysfunction. European Cardiology Review 2020, 15:e13; https://doi.org/10.15420/ecr.2019.14.

2.     Tsao, C.W., Aday, A.W., Almarzooq Z.I., et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. Circulation Vol. 147, No. 8; https://www.ahajournals.org/doi/10.1161/CIR.0000000000001123#d330256e1.

3.     Khazanie P, Allen LA. Systematizing Heart Failure Population Health. Heart Fail Clin. 2020 Oct;16(4):457-466. Doi: 10.1016/j.hfc.2020.06.006. Epub 2020 Jul 21. PMID: 32888640; PMCID: PMC7737815; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737815/.

4.     Anumana data on file (NCT04963218).

5.      Yao, X., Rushlow, D.R., Inselman, J.W. et al. Artificial intelligence–enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial. Nat Med 27, 815–819 (2021); https://doi.org/10.1038/s41591-021-01335-4.

Anumana’s ECG-AI™ Algorithms Honored with 2024 MedTech Breakthrough Award for “Best New Technology Solution-Cardiology”

CAMBRIDGE, Mass. – May 21, 2024 – Anumana, a leading AI-driven health technology company and portfolio company of nference, announced today that it has received the International Organization for Standardization (ISO) 13485 certification for its Quality Management System. This certification, the quality management standard for device manufacturers, indicates that a company has developed robust policies and procedures for the development and manufacture of regulated medical devices. 

Anumana received ISO 13485 certification following an independent third-party certification firm’s rigorous assessment of its Quality Management System. With this certification, Anumana strengthens its ability to provide software-as-a-medical device (SaMD) ECG-AI™ algorithms that consistently meet customer and regulatory requirements. 


“Anumana’s ISO13485 certification is a testament to our commitment to excellence in the development and manufacturing of regulated medical devices that adhere to international standards and requirements,” said David McMullin, Anumana’s chief business officer. “As a rapidly growing international medical device manufacturer, this milestone underscores our leadership in pioneering and bringing to market clinically validated and regulated ECG-AI™ algorithms as SaMDs, validates our capabilities, and enables Anumana to extend the reach of our technology to clinicians and patients worldwide.” 


ECG-AI™ LEF, the company’s FDA-cleared, breakthrough AI algorithm using routine 12-lead ECG data to detect Low Ejection Fraction (LEF), a commonly undiagnosed indicator of heart failure,1 received U.S. FDA clearance in September 2023 and is currently under review in Europe.

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect hidden diseases using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights. 

Anumana’s lead algorithm, ECG-AI™ LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF.

Anumana was named one of Fierce MedTech’s Fierce 15 companies for 2022 and received the 2024 Medtech Breakthrough award for Best New Technology Solution, cardiology.  Follow Anumana at anumana.ai and on LinkedIn and Twitter. 

Jaskanwal D Sara, Takumi Toya, Riad Taher, Amir Lerman, Bernard J Gersh, Nandan S Anavekar. Asymptomatic Left Ventricle Systolic Dysfunction. European Cardiology Review 2020, 15:e13; https://doi.org/10.15420/ecr.2019.14. 


Media Contact: 
Sam Choinski 
Pazanga Health Communications for Anumana
schoinski@pazangahealth.com 
(860) 301-5058

Anumana Demonstrates Global Readiness with Receipt of ISO 13485 Certification

CAMBRIDGE, Mass. – Oct. 24, 2024 – Anumana, a leading AI-driven health technology company and portfolio company of nference, has joined the Accelerating Medicines Partnership® (AMP®) Heart Failure program. Managed by the Foundation of the National Institutes of Health (FNIH), this initiative brings together leaders in academia, industry, and government to advance critical research and improve outcomes for patients.

“We are honored to join leading experts in the AMP Heart Failure program to help advance the next generation of treatments," said Maulik Nanavaty, CEO of Anumana. "While heart disease treatments have seen remarkable progress, heart failure deaths continue to rise. The AMP Heart Failure collaboration is poised to shift that trend. As a dedicated leader in AI-powered clinical solutions, Anumana will bring our expertise in developing and validating AI-enabled Software as Medical Device (SaMD) that identifies diseases from electrocardiogram to advance the goals of the AMP Heart Failure program. By enabling earlier diagnoses, we aim to help improve patient care by starting treatment sooner, and ultimately improving quality of life."

Launched in 2022 in collaboration with the National Heart, Lung, and Blood Institute at the National Institutes of Health (NIH), AMP Heart Failure is a multi-year, multi-center initiative focused on understanding heart failure with preserved ejection fraction (HFpEF), a complex condition in cardiovascular health, through two parallel and interconnected components. The first component is to aggregate clinical data from over 30 existing cohorts and trials to identify subtypes of HFpEF. The second component builds upon the knowledge generated from component one by creating an extensively phenotyped new cohort of HFpEF patients. Utilizing advanced technologies, including digital measurements and AI-driven analytic methods, AMP HF aims to transform care with more precise treatment options, ultimately improving the outlook for millions of patients around the world.

“AMP Heart Failure provides the opportunity to collaborate with partners that are using cutting-edge technologies to lower the risk of mortality in HFpEF patients and improve the quality of life,” said Tania Kamphaus, PhD, Associate Vice President, Science Partnerships, and Director of Patient Engagement at the FNIH. “Anumana will contribute key analytical tools to help deepen our understanding of HFpEF and advance our ultimate goal of developing new treatments.”

Heart failure remains a leading cause of death and hospitalization globally, affecting nearly 6.7 million adults in the U.S. alone.1 As an AMP Heart Failure partner, Anumana will support the innovative program's goals, including unifying large existing real-world datasets and developing new data solutions focused on HFpEF. This expanded dataset also provides Anumana with a unique opportunity to evaluate its ECG-AI algorithms across a broader patient population. By applying its technology to this real-world data, Anumana will facilitate earlier detection of complex heart conditions and drive more personalized treatment strategies.

ECG-AI™ LEF, Anumana’s breakthrough AI algorithm using routine 12-lead ECG data to detect Low Ejection Fraction (LEF) – a commonly underdiagnosed indicator of heart failure2 – received U.S. FDA clearance in 2023 and is currently under review in Europe. Anumana has received FDA Breakthrough Device Designation for three additional algorithms: pulmonary hypertension, cardiac amyloidosis, and hyperkalemia. The company’s algorithms have been studied in more than 75 published clinical studies, effectively identifying conditions such as low ejection fraction and other hidden heart diseases.

Anumana’s award-winning lead algorithm, ECG-AI™ LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF. 

Joynt Maddox et al. Circulation. 2024; v150:n4: https://doi.org/10.1161/CIR.0000000000001256

Sara et al. European Cardiology Review. 2020 Feb:e13: 10.15420/ecr.2019.14

President/CEO, Sampson Public Relations Group
asampson@sampsonprgroup.com

Program provides access to real-world data to refine AI algorithms for earlier detection of complex heart conditions

Anumana Joins Accelerating Medicines Partnership Heart Failure Program to Advance ECG-AI™ Research

Medical Device Network: The US Food and Drug Administration (FDA) has granted breakthrough device designation (BDD) for the electrocardiogram-artificial intelligence (ECG-AI) algorithm by AI-driven health technology company Anumana. The algorithm is intended for the early detection of cardiac amyloidosis, an underdiagnosed cause of heart failure. Anumana has worked with the Mayo Clinic to develop the ECG-AI algorithm. The company previously signed a multi-year research agreement with Pfizer for the development of ECG-AI solutions to facilitate cardiac amyloidosis early identification.

FDA grants breakthrough designation for Anumana’s ECG-AI algorithm

Mass Device: Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device.

Anumana wins FDA clearance for ECG-AI algorithm

DAIC: Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure. This breakthrough device designation was granted to provide patients and healthcare providers timely access to the algorithm, subject to approval.

Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm

Healio: Anumana announced it received FDA breakthrough device designation for its artificial intelligence-guided ECG algorithm for the early identification of cardiac amyloidosis.

AI algorithm for detection of cardiac amyloidosis gains FDA breakthrough device status

Healio: An AI-powered device to identify low left ventricular ejection fraction in patients at risk for HF gained 510(k) clearance from the FDA.

AI-powered device to identify low LV ejection fraction gains FDA 510(k) clearance

Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid physicians in earlier identification of cardiac amyloidosis

CAMBRIDGE, Mass., June 21, 2023 – Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure. This breakthrough device designation was granted to provide patients and healthcare providers timely access to the algorithm, subject to approval. 

Anumana previously announced a multi-year research agreement with Pfizer to develop ECG-AI solutions to aid in early identification of cardiac amyloidosis. The Breakthrough Device Designation recognizes the significant potential of this algorithm, and the designation is a key regulatory milestone under the agreement, providing an expedited pathway for regulatory review.1 Anumana plans to conduct a retrospective clinical validation trial and pursue De Novo classification for the algorithm as Software as a Medical Device (SaMD) and aims to gain regulatory approval for the algorithm for the detection of cardiac amyloidosis in the U.S., Europe, and Japan. 

Cardiac amyloidosis is an underdiagnosed disease that often leads to heart failure.2 Early diagnosis is crucial to enable timely interventions that can improve outcomes.3 However, diagnosing this condition early can be challenging because of the rarity of the disease, which often presents with nonspecific signs and symptoms.4  While a standard ECG is obtained during the evaluation of these nonspecific symptoms, human interpretation of the ECG often misses subtle combinations of features that may indicate cardiac amyloidosis.5,6

Developed in collaboration with Mayo Clinic, Anumana’s ECG-AI algorithm aims to address this medical need with breakthrough technology that facilitates earlier identification of this underdiagnosed condition. Anumana is currently developing this algorithm as a SaMD, with the goal of integrating this solution into existing clinical workflows. 

“The use of AI algorithms to identify subtle signals in ECGs that are imperceptible to humans stands to transform cardiovascular medicine by allowing us to detect disease early, in more easily treated stages, potentially avoiding serious consequences,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester and Chair of Anumana’s Mayo Clinic Board of Advisors. “It is encouraging to see an algorithm that can aid in identification of cardiac amyloidosis receive Breakthrough Device Designation, as it recognizes the importance of having new tools to detect rare cardiac diseases in ways never before possible.”

Anumana, a portfolio company of nference was founded in 2021 in collaboration with the Mayo Clinic Platform and has since developed a robust pipeline of FDA-ready ECG-AI algorithms. These algorithms have been validated in over 75 peer-reviewed publications - including two novel, real-world prospective studies published in Nature Medicine and The Lancet. Anumana has received four Breakthrough Device Designations from the U.S. FDA for algorithms aimed at early identification of low ejection fraction, pulmonary hypertension, hyperkalemia, and now, cardiac amyloidosis. 

“The ubiquitous nature of the painless, non-invasive Electrophysiology tests gives ECG-AI algorithms the potential to reach a larger number of patients earlier, something clinicians have long hoped for,” said Venky Soundararajan, PhD, Co-founder, and Chief Scientific Officer of Anumana and nference. “Receiving the FDA Breakthrough Device Designation for our Cardiac Amyloidosis ECG-AI Algorithm recognizes the significant potential of this tool to detect disease early.” 

Anumana, a leading AI-driven health technology company, and portfolio company of nference, is leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. Anumana’s algorithms have been developed and trained on the nference nSights platform and validated in retrospective and prospective studies across various institutions both nationally and internationally. Anumana’s solutions aim to detect hidden diseases using ECG-AI algorithms and to enhance and improve interventional procedures through real-time AI insights. Currently, four Anumana algorithms have received FDA Breakthrough Device Designation and are currently undergoing rigorous clinical validation. Anumana has also received approval for two CPT® III Codes from the American Medical Association, establishing ECG-AI as a new innovative procedure. Anumana software devices are designed for real-world physician use, integrating into existing workflows at the point of care to reduce costs and enhance quality of life. Anumana was named one of Fierce Medtech’s Fierce 15 companies for 2022. For more information, visit anumana.ai and follow Anumana on LinkedIn and Twitter. 

Sam Choinski
Pazanga Health Communications for Anumana
schoinski@pazangahealth.com
(860) 301-5058

CAMBRIDGE, Mass. – November 5, 2024 – Anumana, a leading artificial intelligence (AI)-driven health technology company, announced that the Centers for Medicare & Medicaid Services (CMS) has included the Company’s low ejection fraction (LEF) ECG-AI™ technology in the 2025 Hospital Outpatient Prospective Payment System (OPPS) final rule under assignment APC 5734. This approval allows outpatient settings to receive reimbursement for using Anumana’s ECG-AI service to help identify LEF in adults at risk for heart failure, aiding early detection of cardiac dysfunction.

“The new CMS reimbursement ruling reflects our efforts to bring our ECG-AI technology to broader patient populations and recognizes our ongoing leadership in AI-enabled cardiovascular care,” said Maulik Nanavaty, CEO of Anumana. “This crucial milestone will help to reduce financial barriers to adopting ECG-AI, facilitating a smooth path for its integration into routine care and ultimately improving patient outcomes in cardiovascular disease management.”

Anumana’s ECG-AI™ technology, which received Category III CPT codes (0764T and 0765T) in 2023, harnesses advanced AI technology to transform standard ECG data into a powerful diagnostic tool for cardiovascular health. By detecting subtle, clinically significant patterns in ECGs that may indicate underlying conditions, ECG-AI™ aims to assist healthcare providers in making earlier and more accurate diagnoses, leading to improved patient outcomes.

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.   

Anumana has received FDA Breakthrough Device Designation for four of its ECG-AI powered algorithms, including those for low ejection fraction, pulmonary hypertension, cardiac amyloidosis, and hyperkalemia. Its award-winning lead algorithm, ECG-AI™ LEF, is now available in the U.S. and currently under review in Europe. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF.  

Company’s ECG-AI algorithm enables earlier heart failure detection

Anumana’s AI-Driven Low Ejection Fraction ECG-AI Technology Recognized in CMS 2025 OPPS Final Rule, Expanding Access to Advanced Cardiovascular Care

Fierce Biotech: For the fourth time in half as many years, Anumana has earned the FDA’s breakthrough device designation for another of its artificial intelligence algorithms designed to catch hard-to-spot heart conditions in their earliest stages.

Anumana's Pfizer-backed cardiac amyloidosis-spotting AI algorithm nabs FDA breakthrough tag

Coherent Market Insights: The global electrophysiology devices market is expected to exhibit a CAGR of 12.6% during the forecast period due to the increasing organic strategies such as acquisition by the key market players. For instance, in November 2022, anumana, Inc., a health technology company, announced that they had acquired NeuTrace, a medical technology company. This acquisition will help anumana, Inc., for the development of electrophysiology platform.

Global Electrophysiology Devices Market to Surpass US$ 20,069.2 Million by 2030, Says Coherent Market Insights (CMI)

Pharma Times: Artificial intelligence (AI) health technology company, Anumana, will collaborate with Pfizer to develop an artificial intelligence electrocardiogram algorithm (AI-ECG), which enables the early detection of cardiac amyloidosis.

Anumana in the News

Anumana Appoints Dr. Simos Kedikoglou as President and Chief Operating Officer

Anumana and AliveCor Collaborate to Advance ECG-AI Algorithms for Early Detection of Cardiac Diseases on Kardia Devices

Anumana Joins the American College of Cardiology to Advance AI-Powered Solutions for Detecting Heart Failure

Anumana Named to Fast Company’s 2024 Next Big Things in Tech Awards

Anumana to Showcase AI-Driven Cardiovascular Solutions at AHA and NAPCRG 2024

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