HeartBeam has gained the US Food and Drug Administration’s 510(k) clearance for its comprehensive arrhythmia assessment system.
The patented high-fidelity electrocardiogram (ECG) HeartBeam device, distinguished by its credit card size and cable-free design, is claimed to be the first of its kind to be cleared by the US regulator.
By using the HeartBeam patient app, individuals can easily place the device on their chest to record a 30-second ECG.
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This data is then transmitted to the cloud, processed, and made available to physicians for review. The assessment takes into account the patient’s medical history and symptoms, enabling timely follow-up and management of the condition.
Designed for use by adults in either clinical or home settings, the portable non-invasive recorder stores and transfers 3-Lead ECG data acquired from five electrodes.
While the device itself does not conduct cardiac analysis, it is compatible with an ECG Viewer software system that allows healthcare professionals to manually interpret non-life-threatening arrhythmias.
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.”
HeartBeam’s technology is anticipated to provide critical diagnostic and predictive insights. The ability to collect high-fidelity ECG signals easily will allow patients to compile recordings over time.
The company plans to integrate AI to analyse this data, offering a longitudinal perspective on cardiac health and the potential to predict cardiac conditions before symptoms manifest. It is preparing to launch an ‘Early Access Program’ and is compiling a waitlist of patients and physicians interested in the technology.
