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HeartBeam’s Heart Attack Assessment Technology Accepted into FDA’s Total Product Life Cycle Advisory Program (TAP) 

$BEATPress releaseOct 26, 2026, 8:31 AM ETRead the release

The FDA has accepted HeartBeam's HeartBeam System into the Total Product Life Cycle Advisory Program (TAP) Pilot for its 3D ECG heart attack assessment technology, awarded ahead of schedule. This follows Breakthrough Device Designation earlier in October, and TAP provides dedicated FDA advisors plus early engagement with payers including CMS, supporting the company's planned pivotal study with patient enrollment anticipated in Q1 2027.

Key figures

Issued patents
more than 25
Mi market opportunity
$15 billion
Cardiac platform opportunity
$40 billion
Pivotal study enrollment start
Q1 2027

AI analysis

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