HeartBeam system accepted into FDA’s TAP pilot; pivotal study enrollment expected in Q1 2027
BEAT•The FDA accepted HeartBeam’s system into its Total Product Life Cycle Advisory Program pilot. HeartBeam expects to begin patient enrollment for a multicenter pivotal study in Q1 2027.
1. FDA pilot acceptance
The FDA accepted HeartBeam’s system into its Total Product Life Cycle Advisory Program (TAP) pilot. HeartBeam expects to begin patient enrollment for a multicenter pivotal study in Q1 2027.
