Caption AI

By GE HealthCare (formerly Caption Health)
· USA
GE HealthCare — AI-guided cardiac ultrasound image acquisition.
Diagnostic
Cardiology
Production
FDA Cleared
Regulatory status
FDA Cleared
Deployment
Production
Clinical role
Adjunct (decision support)
Headquarters
USA
AI type
Diagnostic

Precise indication

AI-guided cardiac ultrasound image acquisition.

Regulatory status

First FDA authorization for an AI-guided image-acquisition system.

Clinical evidence

Vendor-supported

Original FDA-clearance press release (issued under the Caption Health name, before the GE acquisition).

Independent

Not found in this research pass — verify before publishing.

Real-world deployment

Acquired by GE HealthCare in 2023, now part of GE’s portable ultrasound offering; no independent deployment figure found.

Interoperability

European status

Editorial verdict

Limits and uncertainties

Update all material to reflect GE HealthCare ownership — do not present as an independent startup.

Sources

https://www.caption-care.com/press/fda-grants-caption-health-landmark-authorization-for-first-ai-guided-image-acquisition-system

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
GE HealthCare (formerly Caption 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.