Anumana wins FDA clearance for ECG-AI algorithm
Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device.
Cambridge, Massachusetts–based Anumana, an Nference portfolio company, worked in collaboration with Mayo Clinic. They designed the breakthrough medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. The company’s pulmonary hypertension (PH) early detection algorithm also won FDA breakthrough device designation last year.
