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 ...

Lohman Technologies Announces Deeper Strategic Partnership with Salvo Health to Advance Comprehensive Remote GI Care

Lohman Technologies ( innovator of the FDA-cleared HomECG+ medical-grade home ECG monitoring device, today announced a ...
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 ...
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) ...