MobiHealthNews

Omron gets long-awaited FDA nod for combined EKG-blood pressure monitor

This article has been updated with a new photo and additional information from Omron. Omron has apparently finally received FDA 510(k) clearance for its Blood Pressure Monitor + EKG device, which was ...
Morningstar

Huxley Medical's SANSA Receives Diagnostic ECG Clearance from FDA, Paving Way for First Solution to Systematically Detect Arrhythmias During Home Sleep Testing

ATLANTA, Dec. 18, 2025 /PRNewswire/ -- Huxley Medical, Inc. announced the SANSA® home sleep apnea test has received regulatory clearance from the United States Food and Drug Administration (FDA) to be ...
Seeking Alpha

HeartBeam Receives FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment

HeartBeam, Inc. (BEAT) (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that the U.S. Food and Drug ...
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-Low EF Software

CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) ...
Business Wire

Masimo Announces FDA 510(k) Clearance of Radius VSM™

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced that Radius VSM™, a patient-worn, continuous multi-parameter vital signs monitor, has received FDA 510(k) clearance. Designed on ...