FAQ: HeartBeam's Credit-Card-Sized 3D ECG Device and FDA Clearance

What is HeartBeam’s credit-card-sized ECG device?

HeartBeam’s device is a portable, credit-card-sized ECG system that captures three-dimensional signals (up-down, side-to-side, and front-to-back) and uses the company’s algorithm to synthesize a full 12-lead ECG output, enabling hospital-level arrhythmia evaluation outside traditional medical settings.

When did HeartBeam receive FDA clearance for this device?

HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, making it the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions.

How does the HeartBeam device work technically?

The device records three-dimensional signals (up-down, side-to-side, and front-to-back) which HeartBeam’s proprietary algorithm then converts into a standard 12-lead ECG, providing comprehensive cardiac monitoring in a portable format that fits in a wallet or purse.

What partnership has HeartBeam established for this technology?

HeartBeam has partnered with AccurKardia to integrate its FDA-cleared AccurECG software, which provides automated rhythm interpretation and streamlines physician workflows for more efficient cardiac monitoring and analysis.

How can patients use the HeartBeam device?

Patients can carry the device in their wallet or purse for on-demand readings, using the accompanying app for both routine monitoring and symptom-triggered recordings, with data automatically routed to on-call cardiologists when necessary.

What is the current status of HeartBeam’s 12-lead ECG synthesis software?

The 12-lead ECG synthesis software is currently under FDA review, with HeartBeam expecting to receive FDA clearance for the algorithm later this year, which will complete the full functionality of their portable ECG system.

What is HeartBeam’s commercial strategy for this technology?

HeartBeam intends to focus its commercial strategy on preventive cardiology and concierge practices, with ongoing research to expand adoption and demonstrate cost-effectiveness, though reimbursement pathways are still developing.

Where can I find more information about HeartBeam and this technology?

More information is available in the full MD+DI article at https://ibn.fm/fAh84 and in HeartBeam’s newsroom at https://ibn.fm/BEAT, which provides the latest news and updates relating to the company.

What makes HeartBeam’s technology unique compared to traditional ECG systems?

HeartBeam’s technology is unique as it’s the first cable-free device that captures 3D ECG signals from three non-coplanar directions and synthesizes them into a full 12-lead ECG, all in a credit-card-sized portable format that can be used anywhere outside medical facilities.