Eko Health

By Eko Health
· USA
Eko Health — AI-enabled digital stethoscope for atrial fibrillation and heart failure detection.
Diagnostic
Cardiology
Production
FDA Cleared
Regulatory status
FDA Cleared
Deployment
Production
Clinical role
Adjunct (decision support)
Headquarters
USA
AI type
Diagnostic

Precise indication

AI-enabled digital stethoscope for atrial fibrillation and heart failure detection.

Regulatory status

FDA cleared, including a specific clearance for heart-failure detection.

Clinical evidence

Vendor-supported

Vendor press release citing telehealth deployment ‘powering virtual cardiac and pulmonary exams for health systems operating over 800 US hospitals’, plus a named rural use case (Wayne General Hospital, Mississippi).

Independent

The named rural deployment (Wayne General Hospital) is a real, identifiable site, though the announcement itself is vendor-distributed — treat the 800-hospital figure as vendor-reported until independently confirmed.

Real-world deployment

Vendor claims reach across health systems operating 800+ US hospitals, with a concrete named example in an under-resourced rural setting (Mississippi) — a useful equity-of-access example.

Interoperability

European status

Editorial verdict

Limits and uncertainties

The 800-hospital figure is vendor-reported; the rural use case is the more concretely verifiable part of the claim.

Sources

https://www.prnewswire.com/news-releases/eko-telehealth-powers-virtual-cardiac-and-pulmonary-exams-for-health-systems-operating-over-800-us-hospitals-302503658.html

This profile is not medical advice or an endorsement. Hospitals should perform their own due diligence (regulatory compliance, GDPR, cybersecurity, integration, local clinical validation). How we evaluate

At a glance
Vendor
Eko Health
Headquarters
USA
AI type
Diagnostic
Specialty
Clinical role
Adjunct (decision support)
CE marking
Notified body
EU AI Act
Data hosting
Last verified
Reviewed by
How we evaluate

Every profile documents the precise indication, regulatory status, vendor-supported and independent evidence, real-world deployment, limits and dated sources.

A independent systematic review or prospective multicentre study · B at least one independent peer-reviewed study · C peer-reviewed, vendor-supported · D vendor claims only.

Read the methodology →

Spotted an error?

Vendors, authors and clinicians can request a correction. Corrections are dated on the profile.