HeartBeam Inc. Credit-Card-Sized 12-Lead ECG Device FAQ

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

It’s a portable ECG device that captures three-dimensional signals (up-down, side-to-side, and front-to-back) and uses an algorithm to synthesize a full 12-lead ECG output, providing hospital-level arrhythmia evaluation in a compact, wallet-sized format.

When did HeartBeam receive FDA clearance for this technology?

HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software is currently under FDA review with clearance expected later this year.

How does the device work to create a 12-lead ECG?

The device records ECG signals from three non-coplanar directions (3D signals), and HeartBeam’s proprietary algorithm converts these signals into a comprehensive 12-lead ECG output for clinical evaluation.

Who is the target user for this portable ECG device?

The device is designed for patients to carry in a wallet or purse for on-demand readings, allowing them to capture ECG data wherever they are and route it to on-call cardiologists when necessary.

What partnership has HeartBeam established to enhance 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.

Where can this device be used compared to traditional ECG systems?

Unlike traditional hospital-based ECG systems, this portable device can be used anywhere the patient is located, enabling cardiac monitoring outside of medical facilities and redefining remote cardiac health management.

What are HeartBeam’s commercial strategy and focus areas?

HeartBeam intends to focus its commercial strategy on preventive cardiology and concierge practices, with ongoing research to expand adoption and demonstrate the technology’s cost-effectiveness in various healthcare settings.

What intellectual property protection does HeartBeam have for this technology?

HeartBeam holds over 20 issued patents related to the technology enablement of their 3D ECG system and 12-lead synthesis capabilities, providing strong intellectual property protection for their innovations.

How can patients access and use this ECG monitoring system?

Patients can use the accompanying app for both routine monitoring and symptom-triggered recordings, with the data automatically routed to healthcare providers for evaluation and appropriate care direction.

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

More information is available in the company’s newsroom at https://ibn.fm/BEAT and the full article detailing this technology can be viewed at https://ibn.fm/fAh84.