Austin, Texas, United States, June 16th, 2025, FinanceWire
- HeartBeam’s credit card-sized device showed 93.4% diagnostic agreement with standard ECGs
- VALID-ECG study results were presented at the Heart Rhythm Society conference
- The company is looking to commercialize in the U.S. once FDA clearance is granted
HeartBeam (NASDAQ: BEAT) has announced that its synthesized 12-lead ECG met clinical endpoints in the VALID-ECG pivotal study, reaching 93.4% diagnostic agreement with standard ECGs for arrhythmia assessment. The findings were presented by Dr. Thomas Deering of Piedmont Heart Institute at the Heart Rhythm Society’s annual meeting in San Diego and validate HeartBeam’s compact, patient-friendly ECG technology.
The study compared ECG intervals and amplitudes between HeartBeam’s synthesized output and standard ECGs collected at the same time in 198 patients across five U.S. clinical sites. The results support the company’s FDA submission for its ECG synthesis software, which was filed in January 2025.
CEO Robert Eno stressed the importance of enabling accurate, on-demand arrhythmia monitoring outside medical facilities. With FDA clearance expected, HeartBeam has started an Early Access Program to refine clinical workflows and prepare for entry to the U.S. market.
The full press release can be read at https://ibn.fm/XMuzZ
About HeartBeam Inc.
HeartBeam is a medical technology company focused on transforming cardiac care by delivering powerful cardiac insights wherever the patient is. It is developing the first-ever cable-free 12-lead ECG, able to capture the heart’s electrical signals from three dimensions. The platform technology is designed for portable devices that can be used wherever the patient is to provide 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. The company holds 13 U.S. and 4 international-issued patents related to technology enablement. Further information is available at www.HeartBeam.com
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