NetworkNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Gains FDA Acceptance Into TAP Pilot Program for 3D ECG Technology
HeartBeam (NASDAQ: BEAT), a medical technology company focused on cardiac care, announced that the U.S. Food and Drug Administration (“FDA”) has accepted its HeartBeam System into the Total Product Life Cycle Advisory Program (“TAP”) Pilot, following its receipt of Breakthrough Device Designation earlier this month. The program provides dedicated FDA advisors, expedited regulatory feedback and access to healthcare providers, patient advocacy groups and insurers to help accelerate development and patient access. The acceptance applies to HeartBeam’s 3D electrocardiogram (“ECG”) technology being developed to assess potential heart attacks outside traditional medical settings. The company estimates the heart attack assessment market opportunity at approximately $15 billion within a broader cardiac platform opportunity exceeding $40 billion.
HeartBeam expects to seek FDA alignment on its multicenter pivotal study design in the coming months, with patient enrollment anticipated to begin in the first quarter of 2027. The study is intended to support a future regulatory submission expanding the HeartBeam System’s indications to include heart attack assessment. The company is also evaluating eligibility for the Regulatory Alignment for Predictable and Immediate Device (“RAPID”) coverage pathway, designed to accelerate Medicare access to eligible Breakthrough devices. The HeartBeam System is not currently cleared for heart attack detection, and TAP participation does not guarantee future FDA authorization or insurance coverage.
To view the full press release, visit https://nnw.fm/NdfEK
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
HeartBeam (NASDAQ: BEAT), a medical technology company focused on cardiac care, announced that the U.S. Food and Drug Administration (“FDA”) has accepted its HeartBeam System into the Total Product Life Cycle Advisory Program (“TAP”) Pilot, following its receipt of Breakthrough Device Designation earlier this month. The program provides dedicated FDA advisors, expedited regulatory feedback and access to healthcare providers, patient advocacy groups and insurers to help accelerate development and patient access. The acceptance applies to HeartBeam’s 3D electrocardiogram (“ECG”) technology being developed to assess potential heart attacks outside traditional medical settings. The company estimates the heart attack assessment market opportunity at approximately $15 billion within a broader cardiac platform opportunity exceeding $40 billion.
HeartBeam expects to seek FDA alignment on its multicenter pivotal study design in the coming months, with patient enrollment anticipated to begin in the first quarter of 2027. The study is intended to support a future regulatory submission expanding the HeartBeam System’s indications to include heart attack assessment. The company is also evaluating eligibility for the Regulatory Alignment for Predictable and Immediate Device (“RAPID”) coverage pathway, designed to accelerate Medicare access to eligible Breakthrough devices. The HeartBeam System is not currently cleared for heart attack detection, and TAP participation does not guarantee future FDA authorization or insurance coverage.
To view the full press release, visit https://nnw.fm/NdfEK
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
