HeartBeam wins FDA breakthrough tag for at-home heart attack tool

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Go back to HeartBeam wins FDA breakthrough tag for at-home heart attack tool

HeartBeam Receives FDA Breakthrough Device Designation for Heart Attack Assessment

October 5, 2026 8:31 AM EDT

Designation recognizes the potential of HeartBeams 3D ECG technology to help physicians assess suspected heart attacks outside the hospitalBreakthrough status provides prioritized FDA interaction as HeartBeam advances toward a pivotal studyDesignation positions HeartBeam to pursue an expedited Medicare coverage pathwayUpdates on ALIGN-ACS data at TCT and the HEADSTART-ACS study expected in coming weeks

SANTA CLARA, Calif.--(BUSINESS WIRE)--

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