BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Earns FDA Clearance for First Cable-Free ECG System for Arrhythmia Detection

HeartBeam (NASDAQ: BEAT) announced it has received FDA 510(k) clearance for its flagship ECG system, a first-of-its-kind, credit card-sized, cable-free device designed to deliver high-fidelity, three-directional cardiac recordings for arrhythmia evaluation. The clearance marks a major regulatory milestone and accelerates HeartBeam’s plans to improve access to timely, remote cardiac care.

When symptoms arise, patients use the app-guided system to record a 30-second ECG, which is automatically uploaded to the cloud for physician review in the context of medical history. The company will soon launch an Early Access Program to engage early adopters and providers ahead of broader commercialization.

This foundational clearance also sets the stage for future advancements, including 12-lead ECG synthesis, AI-based arrhythmia detection, and remote heart attack risk scoring. HeartBeam’s long-term vision is to revolutionize cardiac care by enabling continuous, predictive insights outside traditional clinical settings.

To view the full press release, visit https://ibn.fm/go8CI

About HeartBeam Inc.

HeartBeam is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The company is creating the first-ever cable-free 12-lead ECG capable of capturing the heart’s electrical signals from three dimensions. This platform technology is designed to be used in 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. The company holds 13 U.S. and 4 international-issued patents related to technology enablement. For more information, visit www.HeartBeam.com .

NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.

BMW is where breaking news, insightful content and actionable information converge.

To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)

For more information, please visit https://www.BioMedWire.com

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer

BioMedWire
Austin, Texas
www.BioMedWire.com
512.354.7000 Office
Editor@BioMedWire.com

BioMedWire is powered by IBN