HeartBeam Stock Soars on FDA Breakthrough Device Designation

HeartBeam (BEAT) shares surged by as much as 90% intraday and closed up 62% at 71 cents per share after the FDA granted its at-home heart attack detection platform Breakthrough Device Designation. The approval process took less than 30 days, nearly half the typical 60-day review period.

The designation does not mean market approval but expedites regulatory clearance and Medicare reimbursement. It also allows HeartBeam enhanced access to FDA personnel during development and review, potentially speeding up its path to market.

HeartBeam’s platform uses proprietary 3D ECG technology, the same as its FDA-cleared arrhythmia monitor. The company estimates the heart attack detection market at $15 billion, with over 20 million at-risk Americans as potential users.

The FDA’s decision was supported by data from the 2025 American Heart Association Scientific Sessions and the ALIGN-ACS pilot study. HeartBeam plans to collaborate with the FDA on a larger, multi-site pivotal trial, with patient recruitment starting soon.