Butterfly iQ+

By Butterfly Network
· USA
Butterfly Network — Point-of-care ultrasound with embedded AI (gestational-age ‘blind sweep’, pulmonary B-line detection, Blueprint interpretation software).
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 (gestational-age ‘blind sweep’, pulmonary B-line detection, Blueprint interpretation software).

Regulatory status

Multiple distinct FDA-cleared AI modules confirmed.

Clinical evidence

Vendor-supported

Vendor press release for the gestational-age tool 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.butterflynetwork.com/press-releases/fda-cleared-gestational-age-tool

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
Butterfly Network
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 →

Spotted an error?

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