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Monday, October 5, 2026

HeartBeam Breakthrough Device Designation for at-home HeartBeam System for heart attack assessment

 

HeartBeam gets FDA Breakthrough Device Designation for at-home HeartBeam System for heart attack assessment

  • Breakthrough designation enables prioritized FDA review of the HeartBeam System for at-home heart attack assessment
  • Status positions the HeartBeam System for an expedited Medicare coverage pathway
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