SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, ...
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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 ...
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 ...
HeartBeam, Inc. (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 ...
The company notes the synthesized output is not intended to replace a standard 12-lead ECG. HeartBeam also plans to advance development of an on-demand 12-lead ECG extended wear monitor and build ...
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 ...
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) ...
LOS ANGELES, CA - December 10, 2025 (NEWMEDIAWIRE) - HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through personalized insights, received FDA 510(k) ...
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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