AliveCor announced today that it received FDA clearance for the next generation of its AI technology for the Kardia 12L ECG ...
AliveCor, the global leader in AI-powered cardiology, today announced it has received U.S. Food and Drug Administration (FDA) ...
HeartBeam Inc. (NASDAQ:BEAT) saw its stock soar 52.6% in premarket trading Wednesday after the company announced that the FDA has granted 510(k) clearance for its 12-lead electrocardiogram (ECG) ...
AliveCor has spent years battling with Apple over the market for consumer heart monitoring technology. Now it’s hoping to make its imprint on professional health care with its new device, which ...
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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 ...
Twelve-lead ECGs, although standard in hospitals, can be bulky and impractical for home use. On the other hand, Apple Watch’s ECG app is easy to use, but it is limited in what it can detect because it ...
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 ...
HeartBeam has received FDA clearance for its synthesized 12-lead ECG software, making it the first cable-free device of its kind for at-home arrhythmia assessment. The clearance followed a successful ...
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 ...
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