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HeartBeam (NASDAQ: BEAT) Secures FDA 510(k) Clearance for 12-Lead ECG Synthesis Software Following Successful Appeal

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, received FDA 510(k) clearance for its 12-lead ECG synthesis software for ...
Digital Trends

I tried a $130 health gadget that beats the Apple Watch in a big way

“Why you can trust Digital Trends – We have a 20-year history of testing, reviewing, and rating products, services and apps to help you make a sound buying decision. Find out more about how we test ...
Business Wire

Wellvii™ and B-Secur Announce Strategic Partnership to Integrate Single-Lead ECG into BP Go, Creating the Most Compact At-Home BP/ECG Combination Device

PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Wellvii Inc., creators of the FDA-cleared blood pressure from the finger that replaces the traditional NIBP arm cuff, today announced a strategic partnership ...

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

FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients ...
Business Wire

HeartBeam Successfully Meets Clinical Endpoints in Pivotal Study for its Groundbreaking 12-Lead ECG Synthesis Technology

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc., (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced ...
Investing

HeartBeam’s 12-lead ECG synthesis software receives FDA clearance

SANTA CLARA, Calif. - HeartBeam, Inc. (NASDAQ:BEAT) announced Wednesday that the U.S. Food and Drug Administration has granted 510 (k) clearance for its 12-lead electrocardiogram (ECG) synthesis ...