HeartBeam has received FDA clearance for its synthesized 12-lead ECG software, making it the first cable-free device of its kind for at-home arrhythmia assessment.
The clearance followed a successful appeal of a previous not substantially equivalent determination, the company said in a Dec. 9 news release. The system uses a three-axis signal capture method to generate a 12-lead ECG without traditional electrode cables.
HeartBeam plans a limited commercial launch in early 2026, focusing on concierge and preventive cardiology practices. The initial rollout will support real-world testing and inform broader distribution.
The company’s future initiatives include a wearable 12-lead ECG patch and an AI-enabled platform trained on longitudinal patient data. HeartBeam said the clearance supports its efforts to expand access to diagnostic ECG data outside traditional care settings.
