Find here all our blog posts tagged with: medical imaging.

A clinician's hand guided by a soft light overlay while holding an ultrasound probe during a vascular scan.

When AI Guides the Hands, Not Just the Read

FDA's clearance of real-time ultrasound guidance AI creates a task-shifting risk category that standard imaging AI governance does not address.

A clinician uses an ultrasound probe while a monitor displays a real-time AI-guided vascular scan.

When AI Guides the Scan, Governance Must Follow the Hands

FDA's clearance of real-time AI ultrasound guidance software shifts imaging AI governance from diagnostic accuracy to human-AI interaction validation.

Split image showing a non-specialist technician capturing an ultrasound scan on one side and a remote physician interpreting it on the other, linked by a data connection.

The Decoupled Diagnostic: Who Owns the Scan

FDA's clearance of AI that lets non-specialists capture diagnostic scans creates a workflow no existing device framework was built to assign liability for.