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 arrhythmias.

The assessment encompasses indications such as atrial fibrillation, sinus rhythm, bradycardia, atrial flutter, tachycardia, and sinus with premature atrial contraction (PAC) or premature ventricular contraction (PVC).

HeartBeam submitted the application based on the pivotal VALID-ECG study data. This trial involved 198 subjects across five clinical centres. Enrolment for the study concluded in June 2024.

Findings from the study suggest that synthesised 12-lead ECG is clinically equivalent to standard ECGs for rhythm and arrhythmia assessment.

This development follows the company’s receipt of FDA 510(k) clearance for its arrhythmia assessment system last month.

In this technology, the heart's electrical signals are captured from three different directions.

Leveraging a personalised transformation matrix, the software aims to synthesise these signals into a 12-lead ECG.

Upon FDA clearance, the company aims to commercially launch the software, building on insights from its Early Access Program.

Future advancements are anticipated to include AI-based classification algorithms and heart attack detection, potentially minimising the critical 'symptom to door' times.

In the pilot study announced last November, which also supports the FDA submission, the company’s synthesised 12-lead ECG demonstrated alignment with standard ECGs for arrhythmia detection, achieving a 94% sensitivity and 100% specificity.

HeartBeam CEO Robert Eno said: “The FDA submission for the 12-lead synthesis software is a significant step as we work towards fulfilling HeartBeam’s vision to offer patients and physicians an easy-to-use portable device and transform how cardiac conditions are monitored and detected.”

The company’s portfolio includes 13 US and four international patents focused on technology enablement.