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