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 ...

NimbleHeart, the Campell, California-based producer of clinical-grade mobile cardiac monitoring devices, announced that its fully reusable ECG device has received FDA clearance and will soon be ...

The U.S. Food and Drug Administration has issued updated guidance on wearable and AI-assisted devices, clarifying distinctions between low-risk wellness products and regulated medical devices. The ...

According to the American Heart Association, if you're at risk of a heart condition or hypertension, it's important to monitor your blood pressure regularly. There are several at-home blood pressure ...

The US Food and Drug Administration has given 510(k) clearance for CardioTag, a wearable sensor designed for cardiovascular monitoring. The device includes an ECG, photoplethysmogram, and ...

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 ...

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) ...

A 2026 informational overview of Herz P1 Smart BPM FDA 510K clearance, wrist blood pressure monitor accuracy considerations, irregular heartbeat detection features, at-home cardiovascular tracking ...