HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its comprehensive arrhythmia assessment system.
Santa Clara, California–based HeartBeam said its device — a high-fidelity electrocardiogram (ECG) system — is the first of its kind to receive FDA clearance. It features a credit card-sized form factor and cable-free design. The device captures heart signals from three distinct directions for actionable heart health information.
When a patient feels symptoms, the app guides them through the process of placing the device on their chest and capturing a 30-second recording. Once taken, the device sends signals to the cloud and processes them before sending them to a physician for review. The physician reviews the ECG recording and follows up with the next steps.
HeartBeam plans to initiate an early access program with a waitlist of interested patients and physicians. The company anticipated this clearance and commercialization effort in October, appointing a new CEO to set it up for growth.
Potential next steps for HeartBeam include a synthesized 12-lead ECG, AI-based classification algorithms and heart attack detection.
“It’s well documented that patients who delay seeking care for their cardiac symptoms face worse clinical outcomes. The ability for patients to capture high-fidelity ECG signals from three directions wherever they are when symptoms occur will help patients get the care they need in a timelier manner,” said Robert Eno, CEO, HeartBeam. “The FDA clearance of our technology is a significant milestone for the Company that brings us one step closer to fulfilling our vision of providing unprecedented cardiac insights to individuals and physicians.”
