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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 ...

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 ...

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 ...

A screenshot from a video demonstrating how to use the HeartBeam ECG device. HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its 12-lead electrocardiogram (ECG) ...

SANTA CLARA, Calif., December 10, 2025--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, ...

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Importance/background The 12-lead ECG is recommended in clinical guidelines for prehospital assessment of patients with suspected acute coronary syndrome (ACS) presenting to Emergency Medical Services ...

Abstract: Synthesizing a 12-lead electrocardiogram (ECG) from non-standard lead systems is increasingly relevant due to the widespread use of wearable ECG devices. This study investigates the ...

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 ...