HeartBeam Secures FDA Clearance for 12-Lead ECG Synthesis Software Following Successful Appeal
TL;DR
HeartBeam's FDA-cleared 12-lead ECG software offers a competitive edge by enabling remote cardiac monitoring, potentially capturing market share in telemedicine and personalized healthcare.
HeartBeam's technology uses cable-free 3D signal capture from five electrodes to synthesize a 12-lead ECG for physician review, with FDA clearance for arrhythmia assessment.
This technology improves cardiac care accessibility by allowing patients to capture ECG data anywhere, facilitating early detection and better management of heart conditions.
HeartBeam's portable 3D ECG device can record heart signals from three directions, creating a synthesized 12-lead readout without traditional cables or clinical visits.
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HeartBeam Inc. (NASDAQ: BEAT), a medical technology company, has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment. The clearance follows a successful appeal of a prior Not Substantially Equivalent (NSE) determination by the regulatory agency. This development marks a significant step forward for the company's cable-free cardiac monitoring technology.
The patented technology captures cardiac electrical signals in three non-coplanar dimensions to generate a synthesized 12-lead electrocardiogram (ECG). This synthesized ECG can be reviewed remotely by a board-certified cardiologist, allowing patients to capture meaningful ECG data wherever symptoms occur. The system is designed for adult patients in either clinical or home settings and does not conduct cardiac analysis itself.
According to the cleared indications for use, the synthesized 12-lead ECG output is intended for manual assessment of normal sinus rhythm and specific non-life-threatening arrhythmias including sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The software is not intended for assessment of other arrhythmias or conditions such as myocardial infarction, ischemia, hypertrophy, conduction disorders, or pacemaker functions. The company emphasizes that the software does not conduct cardiac analysis and is not intended to replace a standard 12-lead ECG.
With clearance secured, HeartBeam plans a limited U.S. launch in early 2026 with select cardiology groups. The company is also advancing other programs including heart attack detection, development of an on-demand 12-lead extended wear patch, and creation of AI-powered screening and prediction algorithms driven by longitudinal data from its 3D ECG platform. The company's 3D ECG technology previously received FDA clearance for arrhythmia assessment in December 2024.
HeartBeam holds over 20 issued patents related to its technology enablement. The company's platform technology is designed for portable devices that can be used wherever the patient is located to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of traditional medical facilities.
For additional information about the company, visit HeartBeam.com. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT. For full safety information, see the full Instructions for Use or Clinician Portal Manual.
Curated from InvestorBrandNetwork (IBN)
