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.
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About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025(1). The Company holds over 20 issued patents related to technology enablement.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://nnw.fm/BEAT
(1)Cleared Indications for Use
The HeartBeam System with 12-Lead ECG synthesis software for arrhythmia assessment received FDA clearance in December 2025. Refer to the Company’s Cleared Indications for Use at https://www.heartbeam.com/indications for details on the intended use of its technology.
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