HeartBeam’s Portable ECG Monitor Gains FDA Approval, Pioneering Mobile Cardiac Care

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A groundbreaking device redefines portable cardiac monitoring, empowering patients with real-time heart health insights.

HeartBeam’s innovative, credit card-sized ECG monitor has received FDA clearance, introducing a cable-free solution for real-time cardiac care. This portable device records clinical-grade 12-lead ECGs within 30 seconds, guided by its mobile app.

Key Features

  • Immediate data sharing: Recordings are sent to the cloud for physician review.
  • Compact design: Enables monitoring from any location, offering unparalleled convenience.
  • Early detection: Promotes timely intervention, reducing risks associated with delayed treatment.

“Providing patients with high-fidelity ECG tools at their fingertips is a milestone toward delivering critical cardiac insights when they are needed most,” said CEO Robert Eno.

Transformative Potential with AI

This clearance marks the beginning of HeartBeam’s vision to revolutionize cardiac care:

  • AI-powered risk detection: Early identification of cardiac events through advanced algorithms.
  • Enhanced diagnostic insights: Expanding the depth of ECG analysis.
  • Global reach: Aiming to elevate cardiac care accessibility worldwide.

Research Supporting Innovation

HeartBeam’s VALID-ECG study, tracking nearly 200 patients, evaluates the monitor’s effectiveness. Branislav Vajdic, PhD, founder and president, emphasized:
“Integrating AI with our 3D VECG technology will provide unique, actionable insights that could revolutionize cardiac care outside traditional clinical settings.”

Redefining Personalized Heart Health

By combining portability, AI, and real-time data sharing, HeartBeam empowers patients to manage their heart health proactively.


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