FDA Status
October
05
2023
October 05, 2023
Anumana earns first full FDA clearance for AI to detect low ejection fraction
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…
October
03
2023
October 03, 2023
Anumana wins FDA clearance for ECG-AI algorithm
Mass Device: Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device.
October
02
2023
October 02, 2023
AI-powered device to identify low LV ejection fraction gains FDA 510(k) clearance
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.
June
22
2023
June 22, 2023
FDA grants breakthrough designation for Anumana’s ECG-AI algorithm
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…
June
22
2023
June 22, 2023
Anumana’s Pfizer-backed cardiac amyloidosis-spotting AI algorithm nabs FDA breakthrough tag
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…
June
21
2023
June 21, 2023
Anumana’s AI algorithm for cardiac amyloidosis gets FDA breakthrough nod
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…
June
21
2023
June 21, 2023
FDA grants breakthrough designation for new AI model to detect cardiac amyloidosis in ECG results
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…
June
21
2023
June 21, 2023
Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis 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…
June
21
2023
June 21, 2023
AI algorithm for detection of cardiac amyloidosis gains FDA breakthrough device status
Healio: Anumana announced it received FDA breakthrough device designation for its artificial intelligence-guided ECG algorithm for the early identification of cardiac amyloidosis.
May
26
2022
May 26, 2022
Way of Diagnosing PH in Common Heart Test Gets FDA Support
Pulmonary Hypertension News: 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…


