Anumana Announces Collaboration with Novartis for AI-ECG Solutions

News

Patients with migraine with aura (MwA) have significantly higher artificial intelligence-enabled electrocardiogram (AI-ECG) atrial fibrillation (AF) prediction model output, according to a study from Mayo Clinic published online June 8 in Headache. The study used Mayo Clinic developed algorithm for detecting atrial fibrillation, which is now licensed to Anumana. 

Migraine with aura identified as independent risk factor for A-fib

Anumana’s electrocardiogram (ECG)-based algorithm for the early detection of pulmonary hypertension (PH) has been designated a breakthrough device by the U.S. Food and Drug Administration (FDA). The technology could help with the significant unmet need for earlier PH diagnoses and treatment start, leading to better outcomes, the company reported in a press release.

Way of Diagnosing PH in Common Heart Test Gets FDA Support

Anumana, Inc., an AI-driven health technology company and portfolio company of nference, has launched a multi-year strategic collaboration with Novartis Pharmaceuticals Corporation (“Novartis”) to deploy a series of artificial intelligence (AI)-powered software solutions that will detect hidden cardiovascular conditions. The collaboration will drive development and delivery of electrocardiogram (ECG) AI algorithms to help physicians accelerate detection and intervention for patients with previously undetected life-threatening heart disease. The ECG AI algorithm is still in development and not yet FDA authorized for commercial clinical use.

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

Developed in collaboration with Janssen and Mayo Clinic, this technology has the potential to aid physicians in earlier detection of pulmonary hypertension, a progressive, life-threatening disease

CAMBRIDGE, Mass., May 24, 2022 – Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Device Designation to its AI-enhanced, ECG-based Pulmonary Hypertension (PH) Early Detection Algorithm. The algorithm is a precise, non-invasive screening tool that addresses an unmet need for earlier diagnosis of patients with pulmonary hypertension, which may otherwise go unnoticed until the disease has advanced, delaying treatment initiation, thereby limiting treatment efficacy and adversely impacting patient outcomes.

FDA Breakthrough Device Designation recognizes novel innovations that demonstrate the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases and helps to accelerate the regulatory process.

“Electrophysiology waveforms hold immense untapped potential for detecting diseases earlier in their natural history, particularly for conditions in which earlier diagnosis and therapeutic intervention can prolong survival and improve quality of life,” said Venky Soundararajan, PhD, co-founder and Chief Scientific Officer of Anumana and nference. “The FDA's Breakthrough Device Designation for Anumana's PH Early Detection Algorithm is one step forward for the field of ECG AI overall, and more saliently, a giant leap forward for PH patients.”

PH is a progressive, life-threatening disease estimated to affect up to 0.1-1% of the global population. 1,2 Due to the non-specific symptoms of the disease, such as shortness of breath, diagnostic delays are common 3,4,5, often longer than a year, and have been linked with a higher mortality risk in certain patient subgroups.6,7

Anumana’s AI-enhanced ECG algorithm is designed to easily and safely detect PH at an earlier stage, by leveraging the widespread availability of 12-lead ECGs in primary care, urgent care, and emergency room settings. The AI-enhanced ECG PH Algorithm is enabled by the nference platform, which provides insight from more than 6 million de-identified patient records, including over 8 million ECGs. It was developed through a collaboration between data scientists and physicians at Anumana, Janssen Research & Development, LLC, and Mayo Clinic. Supported by Mayo Clinic Platform, nference launched Anumana in 2021 to develop and commercialize AI-enabled algorithms.

If approved, the early detection algorithm will be offered as Software as a Medical Device (SaMD) that can be downloaded on a physician’s smartphone, tablet, or computer, or accessed via the Cloud through an Electronic Health Record or ECG Information Management System interface. Using a standard 12-lead ECG, the algorithm analyzes the voltage-time data and within seconds provides a prediction of likelihood of PH, reducing the time between initial symptoms and the first evaluation for PH via targeted cardiac imaging. This early detection algorithm is still in development and not yet approved for clinical use.
 
 “While therapeutic options for patients with pulmonary hypertension have evolved in recent years, we have not seen significant advancement in reducing the time from symptom onset to diagnosis – and our hypothesis was that data science could help change this,” said Najat Khan, PhD, Chief Data Science Officer and Global Head, Strategy and Operations, Janssen Research & Development, LLC. “We leveraged the power of artificial intelligence, the ingenuity of our data scientists and researchers, and deep collaboration to co-develop this AI-based innovation, with the ultimate goal of helping to improve patient outcomes and transform the trajectory of this devastating disease.”
 
 “Early diagnosis of pulmonary hypertension is paramount due to its progression and potential severity,” said Paul Friedman, M.D., chair of the Department of Cardiovascular Medicine at Mayo Clinic. “The addition of AI to a standard ECG – a painless, inexpensive, widely used test that is routinely performed – transforms the ECG into a screening tool for PH, with the opportunity to improve outcomes via early detection by guiding appropriate testing.”

The Pulmonary Hypertension Early Detection Algorithm is the company’s second technology to receive FDA Breakthrough Device Designation. Its low ejection fraction algorithm, developed by Mayo Clinic and licensed by Anumana, received Breakthrough Device Designation in 2019 and Emergency Use Authorization for COVID-19 in 2020. Anumana has a large pipeline of novel algorithms that have been validated by over 30 peer-reviewed publications, including a first of its kind prospective clinical impact study on low ejection fraction that was published in Nature Medicine in 2021. These software solutions are currently in development with each algorithm as a candidate for FDA medical device approval.

About Anumana
 Anumana, an AI-driven health technology company and a portfolio company of nference and Mayo Clinic Platform, is harnessing industry-leading AI and translational science to decode the electrocardiogram as never before – as a deep predictive tool and biomarker of disease – empowering care providers to help patients early. Anumana algorithms have been developed, trained, and validated using clinical data from Mayo Clinic, and are undergoing rigorous clinical trial validation. Anumana is developing AI-enabled ECG algorithms for real-world physician use, integrating point-of-care applications into existing workflows, thereby reducing costs, improving outcomes, and enhancing quality of life. Anumana’s AI-enabled tools can diagnose hidden conditions earlier than ever before. Anumana’s algorithms are investigational medical devices and have not yet received regulatory approval or clearance. For more information, visit anumana.ai and follow Anumana on LinkedIn & Twitter.

About nference
 Through its powerful technology platform and software, nference is transforming health care by making biomedical knowledge computable. Its partnership with Mayo Clinic has given nference an opportunity to synthesize more than 100 years of institutional knowledge, producing real-world evidence in real time by converting large amounts of data into deep insights to advance discovery and development of diagnostics and therapeutics. nference is headquartered in Cambridge, Mass. Follow nference on LinkedIn and Twitter. Visit us at nference.com.

Andrea Sampson, Sampson Public Relations Group

Wijeratne DT, Lajkosz K, Brogly SB, et al. Increasing Incidence and Prevalence of World Health Organization Groups 1 to 4 Pulmonary Hypertension. Circ Cardiovasc Qual Outcomes. 2018;11(2):e003973. doi:10.1161/CIRCOUTCOMES.117.003973

Hoeper MM, Humbert M, Souza R, et al. A global view of pulmonary hypertension. Lancet Respir Med. 2016;4(4):306-322. doi:10.1016/S2213-2600(15)00543-3

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: 67.

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

Rich S, Dantzker DR, Ayres SM, et al. Primary pulmonary hypertension. A national prospective study. Ann Intern Med 1987: 107: 216-223.

Khou V, Anderson JJ, Strange G, et al. Diagnostic delay in pulmonary arterial hypertension: Insights from the Australian and New Zealand pulmonary hypertension registry. Respirol Carlton Vic. 2020;25(8):863-871. doi:10.1111/resp.13768

Klok FA, Barco S, Konstantinides SV, et al. Determinants of diagnostic delay in chronic thromboembolic pulmonary hypertension: results from the European CTEPH Registry. Eur Respir J. 2018;52(6):1801687. doi:10.1183/13993003.01687-2018

FDA Grants Breakthrough Device Designation to Anumana’s ECG Pulmonary Hypertension Early Detection AI Algorithm

Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced the American Medical Association (AMA) has issued new industry-first Category III Current Procedural Terminology (CPT) codes for novel assistive AI algorithmic electrocardiogram risk assessment for cardiac dysfunction, encompassing Anumana’s pipeline of AI-enhanced ECG-based algorithms currently in development for FDA regulatory clearance.

Anumana Announces Issuance of New American Medical Association CPT Category III Codes for Novel ECG AI Analysis of Cardiac Dysfunction

The companies collaborated to develop & deliver new medical device software i.e., ECG AI algorithms for earlier detection of heart disease. The AI will screen for atherosclerotic CV disease which can cause a heart attack or stroke.  An evidence-based, digital point-of-care system will be created in order to improve medical therapies & lower the risk of hospitalizations and CV death

Anumana Entered into a Multi-Year Strategic Collaboration with Novartis to Develop ECG AI Algorithms for the Detection of Heart Disease

Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Device Designation to itsAI-enhanced, ECG-basedPulmonary Hypertension(PH) Early Detection Algorithm. The algorithm is a precise, non-invasive screening tool that addresses an unmet need for earlier diagnosis of patients with pulmonary hypertension, which may otherwise go unnoticed until the disease has advanced, delaying treatment initiation, thereby limiting treatment efficacy and adversely impacting patient outcomes.

Mayo Clinic announced a new technology platform initiative designed to deliver clinical decision support tools, diagnostic insights and care recommendations to help clinicians make faster and more accurate diagnoses and provide continuous care to patients.

Mayo Clinic Launches AI-Focused Diagnostic Platform Ventures

Single-lead ECG tracings from an Apple Watch interpreted by an artificial intelligence (AI) algorithm developed at Mayo Clinic effectively identified patients with a weak heart pump. To interpret ECG signals generated from the single lead on an Apple Watch, researchers modified an established 12-lead algorithm for low ventricular ejection fraction—the weak heart pump—that is licensed to Anumana Inc., an AI-driven health technology company, by nference and Mayo Clinic.

Researchers use AI to detect weak heart pump via patients' Apple Watch ECGs

Researchers in Future Healthcare Journal say that while there are claims from organizations that they’ve developed an AI solution that can “diagnose and treat a disease with equal or greater accuracy than human clinicians,” most of them are based on radiological image analysis. A survey of health care leaders found that while 58 percent are using AI in clinical practice, the most common applications are all related to imaging. 

Promising AI clinical use cases beyond imaging

Early detection and treatment of heart failure can greatly improve an otherwise poor prognosis. Research from Mayo Clinic suggests artificial intelligence could be used to detect the condition even when no symptoms are present. To interpret ECG signals generated from the single lead on an Apple Watch, researchers at Mayo Clinic modified an established 12-lead algorithm used to detect a weak heart pump. That algorithm is licensed to Anumana, an AI-driven health technology company, by nference, which develops software solutions, and Mayo Clinic.

Could AI and an Apple Watch ECG improve the prognosis for heart failure?

Rochester, Minn.-based Mayo Clinic launched two new companies to support its newly developed Remote Diagnostics and Management Platform, which connects data with artificial intelligence technologies for clinical decision support.

Mayo Clinic launches 2 companies in support of new health analytics platform initiative

Mayo Clinic has developed health technology to deliver clinical decision support tools, diagnostic insights and care recommendations so clinicians can make faster and more accurate diagnoses and provide continuous care to patients.

Mayo Clinic platform aids clinical decisions

Mayo Clinic announced a new technology platform initiative to deliver the next generation of clinical decision support tools, diagnostic insights and care recommendations to help clinicians make faster and more accurate diagnoses and provide truly continuous care to patients. The Remote Diagnostics and Management Platform (RDMP) connects data with innovative new artificial intelligence (AI) algorithms and augments human decision-making within existing clinical workflows. RDMP enables "event-driven medicine," providing insights in the right context, at the right time.

Mayo Clinic launches new technology platform ventures to revolutionize diagnostic medicine

The EAGLE—short for ECG AI-Guided Screening for Low Ejection Fraction—trial attempted to establish whether an artificial intelligence (AI) screening tool designed to spot low ejection fraction through EKG data could enhance the diagnosis of this medical disorder in regular practice. The results of the study have been published in the Nature Medicine journal.

New Study Demonstrates Value of AI-Enabled EKG Algorithm in Routine Practice

Heart disease can take a number of forms, but some types of heart disease, such as asymptomatic low ejection fraction, can be hard to recognize, especially in the early stages when treatment would be most effective. The ECG AI-Guided Screening for Low Ejection Fraction, or EAGLE, trial set out to determine whether an artificial intelligence (AI) screening tool developed to detect low ejection fraction using data from an EKG could improve the diagnosis of this condition in routine practice. Study findings are published in Nature Medicine.

Trial demonstrates early AI-guided detection of heart disease in routine practice

Mayo Clinic has announced a new technology platform initiative to new clinical decision support tools, diagnostic insights, and care recommendations to help clinicians make faster and more accurate diagnoses and provide continuous care to patients.

Mayo Clinic launches two new tech companies

An artificial-intelligence algorithm developed at Mayo Clinic could identify left ventricular dysfunction—or a weak heart pump—in most patients based on Apple Watch data, researchers shared at a conference Sunday.

Mayo-developed AI detects heart condition from Apple Watch ECGs

An algorithm developed by the Mayo Clinic can significantly increase the number of cases of low ejection fraction caught in its earliest stages, when it’s still most treatable, according to a study published this month in Nature Medicine.

Mayo Clinic AI algorithm proves effective at spotting early-stage heart disease in routine EKG data

Mayo Clinic has launched two new companies to support its new technology initiative, the Remote Diagnostics and Management Platform. The solution applies artificial intelligence to derive insights from data and uses these findings to support human decision-making within existing clinical workflows. It supports “event-driven medicine” by aiming to provide insights in the right context at the right time.

Anumana announced today that it received FDA breakthrough device designation for its pulmonary hypertension (PH) early detection algorithm. Cambridge, Massachusetts-based Anumana, formed by Mayo Clinic and nference and launched in 2021, designed its AI-enhanced, electrocardiograph (ECG)-based PH early detection algorithm as a precise, non-invasive screening tool to provide earlier diagnosis for patients with PH that may otherwise go unnoticed until the disease has advanced.

Anumana wins FDA breakthrough nod for AI algorithm that detects pulmonary hypertension

The Minnesota-based health care system announced the formation of Anumana Inc. to commercialize artificial intelligence-enabled algorithms and Lucem Health to curate data collected from remote monitoring devices.

Mayo Clinic Launches Two Companies To Support New Remote Monitoring Initiative

Anumana, a startup designing neural network algorithms to enable early detection and accelerate treatment of heart disease, raised $25.7M led by founders nference and Mayo Clinic, with participation from Matrix Capital Management, Matrix Partners, and NTTVC. 

StartUp Health Insights: Virta & 1Doc3 Close Rounds, Over $1.4B Raised This Week

Mayo Clinic shared results of a study showing that an AI tool developed by the system could be used to improve diagnosis of low ejection fraction, a type of heart disease. It's part of a broader push by Mayo Clinic to commercialize AI-based diagnostic tools, starting with spinout company Anumana.

Mayo Clinic finds algorithm helped clinicians detect heart disease, as part of broader AI diagnostics push

Anumana will develop and market algorithms for early detection of disease. Lucem Health can collect device data and feed it into clinical workflows. Both spin-offs aim to capitalize on advances in AI and remote telemetry.

Mayo Clinic launches remote diagnostics platform, forms 2 new companies to support it

Midwest providers eye new financial opportunities

One of the most consequential applications of artificial intelligence (AI) and machine learning (ML) is medicine. Though medical AI is still in its infancy, experts predict that within the next decade, AI-powered technology will enable healthcare providers to dramatically increase the speed, accuracy and quality of medical care from diagnosis to recovery. At the forefront of this endeavor is Mayo Clinic.

Inside Mayo Clinic’s AI Factory: How Mayo Clinic is looking to use AI to enhance patient care and clinical decision making

Using simplified ECG data taken from an Apple Watch, researchers at the Mayo Clinic were able to use an artificial intelligence algorithm to spot people whose hearts may be having trouble pumping blood out to the rest of the body. Previously, the algorithms for analyzing 12-lead ECGs—which have received a breakthrough designation from the FDA and an emergency authorization for use against COVID-19—were licensed by nference and Mayo Clinic to Anumana, an AI developer working on their commercialization.

AI researchers at Mayo Clinic use the Apple Watch to detect silent, weakening heart disease

Anumana has announced the FDA had granted breakthrough Device Designation to its AI-enhanced ECG-based Pulmonary Hypertension (PH) Early Detection Algorithm. Breakthrough Device Designations recognise novel innovations demonstrating potential to provide more effective treatment, or diagnosis for life-threatening or irreversibly debilitating diseases. The designation helps to accelerate the regulatory process.

FDA grants Breakthrough Device Designation to pulmonary hypertension early detection AI

Health technology company Anumana and Novartis Pharmaceuticals Corporation have entered a partnership to use artificial intelligence (AI) for the detection of heart diseases. Under the multi-year collaboration, the companies will seek to deploy multiple AI-powered software solutions that will be able to identify hidden cardiovascular conditions.

Anumana partners with Novartis for AI-driven heart disease detection

Novartis is partnering with algorithms startup Anumana to develop a new artificial intelligence-based solution for cardiovascular diseases. The goal is to find ways to detect heart conditions years before symptoms develop in order to enable earlier intervention.

Novartis turns to algorithms developer Anumana to apply AI to cardio conditions

Anumana Collaborates with Novartis Pharmaceuticals Corporation

Anumana has received US Food and Drug Administration (FDA) Breakthrough Device Designation for its artificial intelligence (AI)-enhanced, electrocardiogram (ECG)-based Pulmonary Hypertension (PH) Early Detection Algorithm. The accurate, non-invasive screening tool aids in addressing an unmet need for early detection of PH in patients.

Anumana’s AI tool for pulmonary hypertension gets FDA breakthrough status

Heart disease remains the leading cause of death around the world, but a flood of tech developers are hoping that artificial intelligence software might be the key to reducing that mortality rate. Latest to join the fray are Novartis and Anumana—a joint venture of the Mayo Clinic and Nference—which have teamed up to develop new AI algorithms. The collaboration is aimed at catching otherwise overlooked cases of life-threatening heart disease as early as possible, even before symptoms arise.

Novartis links up with Mayo Clinic spinout Anumana to develop ECG-reading AI

Health technology company Anumana has entered into a multi-year strategic collaboration with Novartis Pharmaceuticals to detect heart disease leveraging a series of artificial intelligence (AI)-powered software solutions. The partnership will advance the making and distribution of electrocardiogram (ECG) AI algorithms to assist doctors in quickly identifying and treating patients with life-threatening cardiac illnesses.

Anumana and Novartis partner for AI-based heart disease detection

AI-driven health technology company Anumana has received breakthrough device designation from the US Food & Drug Administration (FDA) for its ECG-based Pulmonary Hypertension (PH) algorithm. The AI-enhanced ECG-based early detection algorithm is a precise, non-invasive screening tool that is intended for the early diagnosis of patients with pulmonary hypertension. By using the availability of 12-lead ECGs in primary care, urgent care, and emergency room settings, Anumana’s ECG algorithm is designed to easily and safely detect PH at an early stage.

Anumana wins FDA breakthrough status for AI algorithm to detect PH

Novartis Pharmaceuticals Corporation to collaborate on development of new medical device software for earlier detection and intervention in cardiovascular disease

CAMBRIDGE, Mass., July 13, 2022 – Anumana, Inc., an AI-driven health technology company and portfolio company of nference, has launched a multi-year strategic collaboration with Novartis Pharmaceuticals Corporation (“Novartis”) to deploy a series of artificial intelligence (AI)-powered software solutions that will detect hidden cardiovascular conditions. The collaboration will drive development and delivery of electrocardiogram (ECG) AI algorithms to help physicians accelerate detection and intervention for patients with previously undetected life-threatening heart disease. The ECG AI algorithm is still in development and not yet FDA authorized for commercial clinical use.

The collaboration will support Anumana’s efforts to implement AI-enabled diagnostic software that can detect signals from ECGs that humans cannot interpret. The collaboration will initially focus on cardiovascular diseases. Working with its expert partners from Mayo Clinic, Anumana will deploy novel solutions that use AI to analyze an ECG, a widely available, painless test that records the heart’s electrical signals to identify undiagnosed left ventricular dysfunction, or a weak heart pump, which can lead to heart failure. The AI will also screen for atherosclerotic cardiovascular disease, which can lead to heart attack and stroke. In addition, an evidence-based, digital point-of-care solution will be developed to guide in optimizing guideline-directed medical therapies with the aim to lower risk for potentially avoidable hospitalizations and cardiovascular death. 

“Anumana technology is designed to help physicians identify patients who are at maximum risk of heart failure, long before they develop symptoms,” said Murali Aravamudan, CEO of Anumana. “Bringing together premier global organizations will allow us to expand access to best-in-class, AI-powered digital tools to benefit patients through earlier detection and intervention, when and where health care providers need it most.”

“Many heart diseases develop for years before signs and symptoms appear, but the first event may be life threatening,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic and Chair of Anumana’s Mayo Clinic Board of Advisors. “AI enables us to uncover hidden signals our bodies transmit to detect otherwise occult heart diseases, potentially years before symptoms appear. This collaboration has the potential to transform the use of an ubiquitous inexpensive test, the ECG, with the aim of democratizing disease detection and helping medical care teams to proactively manage heart disease ahead of time and prevent some clinical events from ever happening.”

“Cardiovascular disease is a widespread and multifactorial disease and, in order to mitigate its impact, we must look beyond therapeutic innovation and reimagine how we approach cardiovascular care,” said Victor Bulto, President, Novartis Innovative Medicines US. "Novartis is proud to collaborate with Anumana on innovative and data-driven solutions to better predict the risk of life-threatening heart disease, further driving forward our commitment to improving patient experiences and population health outcomes in this patient population.”  

The Mayo Clinic Cardiology team, led by Dr. Friedman, pioneered the application of AI in cardiology and developed several algorithms based on millions of ECGs, including a low ejection fraction algorithm that received FDA Breakthrough Device Designation in 2019 and Emergency Use Authorization for COVID-19 in 2020. Further validating the technology, a recent study presented by Mayo Clinic used a modified version of Anumana’s 12-lead ECG algorithm to detect left ventricular dysfunction with single-lead ECGs in smartwatches. These algorithms are licensed to Anumana for development of clinical solutions and have been validated by over 30 peer-reviewed publications, including a first of its kind prospective clinical impact study on low ventricular ejection fraction that was published in Nature Medicine in 2021. These software solutions are currently in development with each algorithm as a candidate for marketing authorization through an FDA DeNovo request.

About Anumana
Anumana, an AI-driven health technology company and a portfolio company of nference and Mayo Clinic Platform, is harnessing industry-leading AI and translational science to decode the electrocardiogram as never before – as a deep predictive tool and biomarker of disease – empowering care providers to help patients early. Anumana algorithms have been developed, trained, and validated using clinical data from Mayo Clinic and are undergoing rigorous clinical trial validation. Anumana is developing AI-enabled ECG algorithms for real-world physician use, integrating point-of-care applications into existing workflows, thereby reducing costs and enhancing quality of life. Anumana’s AI-enabled tools can diagnose hidden conditions earlier than ever before. Anumana’s algorithms are investigational medical devices and have not yet received regulatory approval or clearance. For more information, visit anumana.ai and follow Anumana on LinkedIn & Twitter.

Anumana 
Andrea Sampson, Sampson Public Relations Group
asampson@sampsonprgroup.com
562.304.0301

Ground-breaking codes will facilitate the use, adoption, and pathway for potential reimbursement of AI-enhanced ECG-based algorithms, including Anumana’s pipeline of AI- enhanced ECG-based algorithms 

CAMBRIDGE, Mass., July 6, 2022 – Anumana, Inc., an AI-driven health technology company 

from nference, Inc., today announced the American Medical Association (AMA) has issued new industry-first Category III Current Procedural Terminology (CPT®) codes for novel assistive AI algorithmic electrocardiogram risk assessment for cardiac dysfunction, encompassing Anumana’s pipeline of AI-enhanced ECG-based algorithms currently in development for FDA regulatory clearance. 

This ground-breaking approval is a major milestone for AI in cardiology, recognizing Anumana’s AI-enhanced ECG-based algorithms as innovative technology necessitating the creation of a new procedure category. CPT Category III codes are designed to facilitate the use, adoption, and potential reimbursement of emerging technologies. The newly approved AMA CPT Category III codes were published on July 1, 2022, and will be effective on January 1, 2023. 

“We are delighted that the American Medical Association has approved our application for a new category of CPT codes covering our AI-enhanced ECG algorithm pipeline,” said David McMullin, Chief Business Officer at Anumana. “The new AMA codes mark a significant milestone for Anumana, validating the potential impact of our innovative technology and establishing a pathway for widespread adoption and reimbursement.” 

Anumana’s robust pipeline of novel algorithms has been validated by over 50 peer-reviewed publications, and are currently in development as medical devices. Anumana’s pulmonary hypertension algorithm received FDA Breakthrough Device Designation earlier this year, and its low ejection fraction algorithm received FDA Breakthrough Device Designation in 2019 and Emergency Use Authorization for COVID-19 in 2020. 

Anumana, an AI-driven health technology company and a portfolio company of nference and Mayo Clinic Platform, is harnessing industry-leading AI and translational science to decode the electrocardiogram as never before – as a deep predictive tool and biomarker of disease – empowering care providers to help patients early. Anumana algorithms have been developed, trained, and validated using clinical data from Mayo Clinic and are undergoing rigorous clinical trial validation. Anumana is developing AI-enabled ECG algorithms for real-world physician use, integrating point-of-care applications into existing workflows, thereby reducing costs and enhancing quality of life. Anumana’s AI-enabled tools can diagnose hidden conditions earlier than ever before. Anumana’s algorithms are investigational medical devices and have not yet received regulatory approval or clearance. For more information, visit anumana.ai and follow Anumana on LinkedIn & Twitter. 

Anumana
 Andrea Sampson
 Sampson Public Relations Group asampson@sampsonprgroup.com 562.304.0301 

Anumana Announces Issuance of New American Medical Association CPT® Category III Codes for Novel ECG AI Analysis of Cardiac Dysfunction

One of the companies, Anumana, is seeking clearance from the Food and Drug Administration to market an artificial-intelligence tool to detect heart conditions.

An AI algorithm developed by researchers at the Mayo Clinic through its newly formed health technology company Anumana Inc., can assess for low ejection fraction through routine electrocardiograms (ECG, or also called EKG). The ECG-based AI-powered clinical decision support tool can enable diagnosis of low ejection fraction, especially in its earliest stages to facilitate more prompt diagnosis and treatment of the heart condition. In a clinical trial that evaluated the tool, the researchers found that it was able to detect an increased number of low ejection fraction cases in the earliest stages of the condition.

How a New AI Algorithm Could Help in the Early Detection of Heart Disease

Artificial Intelligence (AI) continues to improve the healthcare industry. Capitalizing on AI’s many applications, Mayo Clinic is currently launching two new ventures, Anumana and Lucem Health, in order to utilize AI capabilities for preventative and diagnostic care. 

Mayo Clinic Launches Two Companies To Improve AI Diagnostic And Preventative Care

Heart disease can take a number of forms, but some types of heart disease, such as asymptomatic low ejection fraction, can be hard to recognize, especially in the early stages when treatment would be most effective. The ECG AI-Guided Screening for Low Ejection Fraction, or EAGLE, trial set out to determine whether an artificial intelligence (AI) screening tool developed to detect low ejection fraction using data from an EKG could improve the diagnosis of this condition in routine practice. Study findings are published in Nature Medicine.

A Mayo Clinic and Janssen-backed venture has received FDA breakthrough designation for an algorithm designed to enable early detection of pulmonary hypertension. Anumana Inc. received the breakthrough device designation for its AI-enhanced, ECG-based algorithm screening tool that provides early diagnosis of patients with pulmonary hypertension, according to a May 24 press release.

Mayo Clinic, Janssen-backed venture gets FDA OK for pulmonary hypertension AI algorithm

For years, data analytics in healthcare has been a frequent buzzword among industry leaders. The ability to leverage AI, machine learning, and other technologies to gain actionable insights from massive amounts of data is an exciting prospect, but one that has been notoriously difficult to realize. With the onset of the pandemic, healthcare was forced to come face-to-face with its many data challenges, from collection to accuracy and analysis. In response, the industry has ramped up its efforts to improve data analytics capabilities – with tech companies playing a major role. 

Tech Companies Aim to Expand Use of Data Analytics in Healthcare

Mayo Clinic has launched a new initiative to collect and analyze patient data from remote monitoring devices and diagnostic tools and to use artificial intelligence to accelerate diagnoses and disease prediction. To support this effort, the hospital is launching two new companies, Anumana and Lucem Health, which are working with AI and medical algorithms that tap into the hospital's patient data.

Mayo Clinic launches 2 new companies to use patient data and AI to advance early disease detection

Mayo Clinic is launching two new companies as part of its bid to harness patient data and use it to deliver AI-guided care.

Mayo Clinic launches two companies to tap patient data for AI tools

Mayo Clinic last month released a study suggesting that an artificial intelligence (AI) algorithm could be used to better diagnose a certain heart condition called low ejection fraction—one step in the Clinic's effort to incorporate AI into cardiac care more broadly.

How Mayo Clinic is using AI to spot hidden heart conditions

Artificial intelligence (AI) screening helps detect low ejection fraction using data from an EKG could improve the diagnosis of this condition in routine practice. Study findings are published in Nature Medicine.

AI-guided Detection of Heart Disease in Routine Practice

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Mayo Clinic struck two joint ventures to develop and commercialize AI diagnostic tools. The idea was to develop algorithms to support clinicians’ decisions, starting with a suite of cardiology tools. The news comes a little over a month after Mayo Clinic announced it plans to create an “AI factory” as it expands its partnership with Google.

Mayo Clinic launches two joint ventures to build, commercialize diagnostic AI tools

An artificial intelligence (AI) algorithm that uses data from electrocardiography can help increase the diagnosis of low ejection fraction (EF), according to a study published online May 6 in Nature Medicine.

AI Algorithm Aids Early Detection of Low Ejection Fraction

Patients with a weak heart pump were identified using single-lead ECG tracings from an Apple Watch interpreted by an artificial intelligence (AI) algorithm developed at Mayo Clinic. Researchers modified an existing 12-lead algorithm for low ventricular ejection fraction — the weak heart pump — that is licensed to Anumana Inc., an AI-driven health technology company, by nference and Mayo Clinic, to interpret ECG signals produced from the single lead on an Apple Watch.

Single-Lead ECG Tracings from an Apple Watch Effectively Identifies Patients with a Weak Heart Pump

An exclusive Tech Tribune Q&A with Venky Soundararajan (co-founder and CSO) of nference, which was honored in our: 2022, 2021, 2020 Best Tech Startups in Cambridge. 

Artificial intelligence (AI)-driven healthtech company, Anumana has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its AI-enhanced, ECG-based pulmonary hypertension (PH) early detection algorithm.
The precise and non-invasive screening tool supports earlier PH diagnosis, which may otherwise not be noticed until the disease has advanced, delaying treatment and limiting efficacy while adversely impacting outcomes.

Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status

Mayo Clinic announced that it is introducing a new technology platform to support two new companies it has launched. Rochester, Minn.–based Mayo Clinic’s Remote Diagnostics & Management Platform (RDMP) is designed to connect data with new AI algorithms and augment human decision-making within existing clinical workflows, according to a news release.

Mayo Clinic helps launch two new companies for improved diagnostics

Mayo Clinic announced a new technology platform and launched two new companies April 14 that promise to improve doctors’ ability to spot disease early by connecting data from remote medical devices with AI-enabled algorithms. The first target is the heart.

New Ventures To Use AI To Target Heart Disease

Anumana in the News

Migraine with aura identified as independent risk factor for A-fib

Novartis turns to algorithms developer Anumana to apply AI to cardio conditions

Anumana Entered into a Multi-Year Strategic Collaboration with Novartis to Develop ECG AI Algorithms for the Detection of Heart Disease

Anumana partners with Novartis for AI-driven heart disease detection

Anumana Collaborates with Novartis Pharmaceuticals Corporation