Mammography (2D and tomosynthesis/DBT) independent reading / double reading.
FDA clearance for ProFound AI v3.0 (3D tomosynthesis, March 2021) and ProFound Detection v4.0 (later clearance).
Press releases (BioSpace, Nasdaq, itnonline).
Independent comparative study published in Radiology: Imaging Cancer (RSNA journal) — ‘Clinical Value and Comparison With Human Performance’; exact figures not yet extracted, verify before publishing.
No verifiable site count found in this research pass.
Detailed independent-study figures (sample size, sensitivity/specificity) not yet extracted — complete before publishing.
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.