The FDA has granted 510(k) clearance to Biofourmis’ RhythmAnalytics, a cloud-based software product that uses deep learning to read and interpret cardiac arrhythmias.
According to a statement from the company and the FDA’s clearance letter, RhythmAnalytics collects single-lead ECG data from a range of FDA-cleared devices, and from these scan for more than 15 types of cardiac arrhythmias,...
