FDA Grants Breakthrough Device Designation For HeartBeam System For Heart Attack Detection

(RTTNews) - HeartBeam (BEAT) announced the FDA has granted Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home. The Breakthrough Device Designation was supported by proof-of-concept data from the 134-patient ALIGN-ACS pilot study. The company expects to seek FDA alignment on the design of a multicenter pivotal study in the coming months and anticipates beginning patient enrollment shortly thereafter.

The company noted that the FDA granted the designation within 30 days of HeartBeam's request, well ahead of the agency's 60-day statutory review period. The designation provides HeartBeam with prioritized FDA review.

In pre-market trading on NasdaqCM, HeartBeam shares are up 30 percent to $0.5871.

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