Lunit INSIGHT MMG

By Lunit
· South Korea
Lunit — Breast cancer detection on mammography.
Diagnostic
Radiology
Production
FDA Cleared
Regulatory status
FDA Cleared
Deployment
Production
Clinical role
Adjunct (decision support)
Headquarters
South Korea
AI type
Diagnostic

Precise indication

Breast cancer detection on mammography.

Regulatory status

FDA cleared.

Clinical evidence

Vendor-supported

Vendor press release citing ‘330+ sites and 1M annual screenings’, covering over 14% of the Italian population via the public health system.

Independent

Not found in this research pass — the deployment figure above is vendor-reported; verify before publishing.

Real-world deployment

‘330+ sites and 1M annual screenings’ claimed by the vendor, notably including deployment within a PUBLIC national health system (Italy), not only private clinics.

Interoperability

European status

Editorial verdict

Limits and uncertainties

Deployment scale is vendor-reported; seek independent confirmation (e.g. from the Italian health authority) before publishing as fact.

Sources

https://www.prnewswire.com/news-releases/lunit-surpasses-330-sites-and-1m-annual-screenings-as-breast-imaging-ai-moves-into-clinical-practice-302744532.html

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
Lunit
Headquarters
South Korea
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.