Exo Iris

By Exo Imaging
· USA
Exo Imaging — Point-of-care ultrasound with embedded AI for cardiac, pulmonary and pleural-effusion detection.
Diagnostic
Point-of-Care Ultrasound
Production
FDA Cleared
Regulatory status
FDA Cleared
Deployment
Production
Clinical role
Adjunct (decision support)
Headquarters
USA
AI type
Diagnostic

Precise indication

Point-of-care ultrasound with embedded AI for cardiac, pulmonary and pleural-effusion detection.

Regulatory status

FDA cleared; described as the first FDA-cleared ultrasound AI for pleural effusion/atelectasis detection.

Clinical evidence

Vendor-supported

Vendor press release for the clearance.

Independent

Not found in this research pass — verify before publishing.

Real-world deployment

Not independently quantified in this research pass.

Interoperability

European status

Editorial verdict

Limits and uncertainties

No independent evidence found in this pass.

Sources

https://www.exo.inc/article/exo-launches-the-first-fda-cleared-ultrasound-ai-for-detection-of-pleural

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
Exo Imaging
Headquarters
USA
AI type
Diagnostic
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 →

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