MD&M East

HeartBeam’s Algorithm Synthesizes a 12-Lead ECG Output in a Credit-Card-Sized Device

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 ...
Business Wire

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

Company engaging in multiple options for a constructive resolution Strategy is underpinned by a clinical study that achieved the agreed upon endpoints Company believes that labeling modifications can ...
Business Wire

First Patients Enrolled in Pivotal Study Evaluating HeartBeam’s AIMIGo™ System for Synthesizing a 12-Lead ECG

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that ...
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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 ...