HeartBeam’s Heart Attack Assessment Technology Accepted into FDA’s Total Product Life Cycle Advisory Program (TAP)
Key Highlights
- ➤HeartBeam System accepted into FDA’s TAP Pilot for heart attack assessment technology
- ➤FDA Breakthrough Device Designation preceded TAP acceptance earlier this month
- ➤Pivotal study patient enrollment expected to begin in Q1 2027
- ➤HeartBeam estimates myocardial infarction market opportunity at approximately $15 billion
- ➤HeartBeam is evaluating eligibility for CMS-FDA RAPID coverage pathway
Expert Statements
Branislav Vajdic, Founder and President of HeartBeam
“Acceptance into TAP, just weeks after Breakthrough Device Designation, gives us a structured partnership with FDA advisors and ongoing access to the stakeholders who will help determine how quickly patients can benefit from our 3D ECG technology for heart attack assessment, our top strategic priority”
Branislav Vajdic, Founder and President of HeartBeam
“We’ve already held our first meeting with our TAP advisors, and we are very excited about the level of engagement the FDA is providing the Company. We believe this positions us to move faster toward giving physicians objective, clinical-grade ECG information when heart attack symptoms begin, wherever the patient is.”
HeartBeam’s Heart Attack Assessment Technology Accepted into FDA’s Total Product Life Cycle Advisory Program (TAP)
* Acceptance into FDA’s TAP Pilot follows Breakthrough Device Designation granted earlier this month for HeartBeam’s heart attack assessment technology * TAP Pilot provides dedicated FDA advisors and early engagement with payers, including CMS, as well as patient and provider organizations, to help accelerate future reimbursement and patient access * Two FDA program milestones in less than one month underscore accelerating momentum behind HeartBeam’s myocardial infarction (MI) program HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, today announced that the U.S. Food and Drug Administration (FDA) has accepted the HeartBeam System into its Total Product Life Cycle Advisory Program (TAP) Pilot, a voluntary FDA program to accelerate patient access to Breakthrough medical devices. The acceptance, which was awarded ahead of schedule, applies to HeartBeam’s 3D ECG technology, which received FDA Breakthrough Device Designation earlier this month, as a tool for assessing potential heart attacks outside of a medical setting.
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