Fact checked byRichard Smith

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June 27, 2023
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AI-based next-generation digital stethoscope cleared by FDA, launched

Fact checked byRichard Smith
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Key takeaways:

  • A next-generation digital stethoscope for detection of abnormal heart rhythms has been cleared by the FDA.
  • The device is used with artificial intelligence software.

Eko Health announced the FDA clearance and launch of its artificial intelligence-based next-generation digital stethoscope for detection of abnormal heart rhythms.

The device (Core 500) combines AI software, high-fidelity audio, full color display and 3-lead ECG, according to a press release from the company.

Generic FDA News infographic

Designed for use with the company’s other AI-based products, the digital stethoscope can flag arrhythmias such as atrial fibrillation, bradycardia and tachycardia in seconds and includes sound amplification, noise cancellation and three audio filter modes, the company stated in the release.

Paul A. Friedman

“As cardiovascular disease rises with our aging population, noninvasive tools like the Core 500 turn a patient interaction into a potential disease screening,” Paul A. Friedman, MD, FHRS, chair of cardiovascular medicine at Mayo Clinic in Rochester, Minnesota, said in the release. “Supported AI diagnostics software, advanced audio technology and 3-lead ECG make this a useful tool for clinicians. The live ECG tracing on the display will help identify patients with previously unknown arrhythmias at the point of care.”