HeartBeam wins FDA Breakthrough Device status for at-home heart attack assessment system
BEAT•The FDA granted Breakthrough Device Designation to HeartBeam’s system for at-home assessment of suspected heart attacks, ahead of a planned multicenter pivotal study.
1. FDA designation
The designation supports prioritized FDA engagement as HeartBeam prepares a planned multicenter pivotal study to expand the system’s indications. It could also support an expedited Medicare coverage pathway once the device receives clearance.
