HeartBeam Secures FDA Clearance for 12-Lead ECG Synthesis Software Following Appeal – Citybuzz

FDA clears HeartBeam’s cable-free, 12-lead ECG for at-home use - BioTuesdays

HeartBeam (NASDAQ: BEAT) has announced that the FDA has granted 510(k) clearance for its first-ever, cable-free, 12-lead electrocardiogram (ECG) synthesis software for the at-home assessment of arrhythmias. According to HeartBeam, this clearance follows HeartBeam’s successful appeal of a prior Not Substantially Equivalent (NSE) determination. In a statement, Robert Eno, CEO of HeartBeam commented, “The company wishes to thank the FDA for its exp…

FDA clears HeartBeam’s at-home arrhythmia assessment tool

HeartBeam has secured US Food and Drug Administration (FDA) clearance for its 12-lead electrocardiogram (ECG) synthesis software, setting the arrhythmia assessment tool up for deployment in patients’ homes.The post FDA clears HeartBeam’s at-home arrhythmia assessment tool appeared first on Medical Device Network.

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 Anytime, Anywhere Pivotal Milestone Unlocks Mul... L'articolo HeartBeam Receives FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment è un contenuto originale di 01net.

HeartBeam Secures FDA Clearance for 12-Lead ECG Synthesis Software Following Appeal – citybuzz

HeartBeam Inc. (NASDAQ: BEAT) has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment following a successful appeal of a prior not substantially equivalent (NSE) determination. The clearance represents a significant regulatory milestone for the medical technology company, which focuses on transforming cardiac care through personalized insights. The company’s patented cable-free technology captures cardi…