HeartBeam secures FDA clearance for at-home ECG system

Credit: HeartBeam, Inc.

HeartBeam, Inc., announced it has received U.S. Food and Drug Administration 510(k) clearance for its HeartBeam system, a credit card-sized device is the first-of-its-kind cable-free ambulatory electrocardiogram (ECG) system cleared for comprehensive arrhythmia assessment, the company said in a news release.

“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, Chief Executive Officer of HeartBeam in a news release. “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.”

According to the company, the HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) ECG acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or other health care professional.

Patients can use the HeartBeam device whenever they experience symptoms, guided by an accompanying smartphone app. The device takes a 30-second ECG recording, which is then uploaded to the cloud for a physician to evaluate. By offering multiple directional views of the heart’s electrical activity, HeartBeam says its system can provide “actionable heart health information.”

As part of its go-to-market strategy, HeartBeam plans to initiate an Early Access Program to gather feedback from patients and physicians prior to a commercial launch.

Future system advancements are also underway, including a personalized transformation matrix to create synthesized 12-lead ECGs and AI-based algorithms aimed at improving arrhythmia detection. The company cites research indicating this technology may improve the identification of heart conditions such as atrial flutter and coronary occlusions.

HeartBeam holds more than a dozen U.S. patents and four international patents related to its ECG technology, according to the news release.