Multi-pathology triage platform on CT (stroke, pulmonary embolism, fractures and other findings) under one workflow layer, including a Breakthrough-Device-designated AI report-generation module.
Numerous FDA 510(k) clearances across indications; one module (AI-generated reports) holds FDA Breakthrough Device designation.
Vendor press release announcing the report-generation clearance.
Not found in this research pass — verify before publishing.
Described as deployed in a very large number of US hospitals; exact figure not found in this research pass.
Deployment scale claimed by the vendor, not independently audited in the sources gathered so far.
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
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.
Vendors, authors and clinicians can request a correction. Corrections are dated on the profile.