US-based medical technology company HeartBeam has received the US Food and Drug Administration (FDA) 510(k) approval for its comprehensive arrhythmia assessment system.
The high-fidelity electrocardiogram (ECG) system is designed to capture the heart’s signals from three different directions to provide actionable heart health information.
HeartBeam has patented the system’s credit card-sized form factor and cable-free design.
Patients with arrhythmia symptoms can use the HeartBeam patient app, which guides them through capturing a 30-second ECG recording by placing the device on their chest.
Once the recording is captured, the system sends the signals to the cloud, where the ECG data is processed and then sent to a physician for review.
The physician evaluates the ECG recording considering the patient’s symptoms and medical history and discusses the next steps with the patient.
HeartBeam is planning to begin an Early Access Programme for the new ECG system and is creating a waitlist of interested patients and physicians.
HeartBeam CEO Robert Eno said: “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.
“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 HeartBeam, the FDA approval supports its planned advances that simplify access to intelligent and actionable 12-lead ECGs for both patients and physicians.
The advances include synthesising the heart’s signals collected from three directions into a 12-lead ECG using a personalised transformation matrix, based on its pilot study.
Earlier this year, the company’s data showed that its deep learning algorithm can improve the detection of atrial flutter, even better than cardiologists in detecting some arrhythmias.
A study published in JACC showed that HeartBeam’s ambulatory technology is comparable to a standard 12-lead ECG in accurately identifying coronary occlusions.
In addition, a feasibility study also confirmed that HeartBeam’s technology can calculate a heart attack risk score to evaluate chest pain remotely.
Furthermore, the company aims to use AI to analyse the rich data to assess patients’ cardiac health and predict cardiac conditions before symptoms appear.
