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HeartBeam submits 510(k) application to FDA for ECG software
HeartBeam has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its 12-lead electrocardiogram (ECG) synthesis software tailored to assess various cardiac rhythms and ...
Nature2y
Artificial intelligence algorithm aims to rapidly diagnose cardiac problems
The AiTiA ECG Center detected an atypical beat and WPW; the requesting doctor decided ... The AI platform can create the full ECG 12-lead channel from one channel or six channels.
TMCnet15d
HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software
The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites. The Company believes the study's findings support the clinical ...