HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac care, announced its participation as a contributing partner in the launch of EXIT-CVD, a European cardiovascular research initiative co-funded by the European Union Innovative Health Initiative and industry partners. The consortium, led by University Medical Center Groningen and Royal Philips, brings together 42 organizations across 17 countries to conduct 22 clinical studies involving more than 14,000 patients, supported by a total budget of 27.6 million euros.
HeartBeam will lead the HEART-CHECK study, which will evaluate its portable electrocardiogram (ECG) system for early detection and triage of cardiac events in high-risk patients recently discharged following acute coronary syndrome. The study will assess the system’s clinical performance and integration into real-world care pathways.
The HeartBeam System recently received U.S. Food and Drug Administration Breakthrough Device Designation for at-home heart attack assessment, an application that remains investigational. This designation is intended to expedite the development and review of devices that provide more effective treatment or diagnosis of life-threatening conditions.
HeartBeam’s technology is designed to transform 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. The company holds over 20 issued patents related to technology enablement. For details on the intended use of its technology, refer to the company’s Cleared Indications for Use.
The participation in EXIT-CVD and leadership of the HEART-CHECK study could significantly impact the cardiovascular monitoring market. By validating its portable ECG system in a large European study, HeartBeam may accelerate adoption of its technology in both European and global markets. This could lead to more efficient triage of post-acute coronary syndrome patients, potentially reducing hospital readmissions and improving patient outcomes. The study’s findings could also support regulatory submissions in Europe and beyond.
For investors, this news highlights HeartBeam’s progress in clinical validation and its potential to capture a share of the growing remote cardiac monitoring market. The latest updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT. The full press release can be viewed at https://ibn.fm/52Qtj.
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