Healio

FDA clears algorithm to reduce ECG noise on ambulatory monitoring

Please provide your email address to receive an email when new articles are posted on . Algorithms to improve ECG interpretability received FDA clearance. The solution is designed to reduce noise ...
Business Wire

Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib

CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug ...
Yahoo Finance

HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis

Southlake, TX, June 04, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”) powered medical technology company ...
Nasdaq

HeartSciences: FDA Grants Breakthrough Device Designation For Aortic Stenosis ECG Algorithm

(RTTNews) - HeartSciences (HSCS, HSCSW) announced that the FDA has granted Breakthrough Device designation for its Aortic Stenosis ECG algorithm. The algorithm would offer a AI-driven ECG solution ...