HeartBeam Provides Update on Regulatory Path Following FDA Decision on 12-Lead ECG Synthesis Software Application ...

A new heart monitoring system combining 3D printing and artificial intelligence could transform the way doctors measure and ...

HeartBeam is pursuing several parallel paths to address the FDA’s concerns, including a potential appeal process or resubmission of a 510 (k) application. The company noted that the appeal process ...

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HeartBeam (BEAT) announced its regulatory strategy following receipt of a Not Substantially Equivalent, or NSE, decision on the company’s 510(k) ...

HeartBeam shares jumped 40.75% in after-hours trading after the company outlined its regulatory strategy following the FDA's Not Substantially Equivalent decision.

A new heart monitoring system combining 3D printing and artificial intelligence could transform the way doctors measure and diagnose patients' heart ...

Cambridge Heartwear Ltd., a trailblazer in medical device innovation and AI technology, is transforming the cardiovascular ...

Smartwatch trends in 2025 bring larger screens, advanced sensors, and AI-driven health tracking, making wearable tech updates ...