Lunit INSIGHT
Lunit · Screening + hospital · Cloud + on-prem
Imaging & Diagnostic AI
FDA-cleared mammography (DBT), chest X-ray, and CT algorithms with published detection-performance studies and broad international deployment.
Evidence at a glance
Freshness, source-checked counts, confidence and gate results below reflect the frozen evidence snapshot through . A later editorial review does not update these results.
- Stated intended users
- Imaging centers, hospital radiology, screening programs
- Documentary gate at snapshot
- Failed
- Scenario match
- Matches this scenario — FDA-cleared imaging AI platforms
- Comparability
- Not yet comparable in this scenario
- Decision readiness at snapshot
- HISTORICAL — Research only
- Documented evidence at snapshot
- 0 of 2 evidence claims source-checked · confidence Low
- Critical unknowns
- No critical documentary gaps identified
- Latest checked-source retrieval in snapshot
- not yet measured
Expand each claim to inspect its source, dates and recorded verification status.
independent reportLunit INSIGHT DBT (V1.2) FDA clearance listed March 2026 on the FDA AI-enabled device list.2026-03-26
Exact claim. Lunit INSIGHT DBT (V1.2) FDA clearance listed March 2026 on the FDA AI-enabled device list.
- Source
- fda.gov
- Type
- independent report
- Published
- 2026-03-26
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- trust_governance
- Score contribution
- Feeds trust governance
Independent source. Methodology and sample vary by report; read the underlying method.
Open fda.govpeer reviewed studyLunit INSIGHT MMG (Lancet Digital Health 2020): the AI algorithm was developed and validated on 170,230 mammography examinations from five i…2020-03-01
Exact claim. Lunit INSIGHT MMG (Lancet Digital Health 2020): the AI algorithm was developed and validated on 170,230 mammography examinations from five institutions; in a multicentre, observer-blinded reader study of 320 mammograms read by 14 radiologists, AI performance (AUROC 0.940) significantly exceeded radiologists without assistance (AUROC 0.810, p<0.0001), and AI assistance improved radiologists' performance to AUROC 0.881 (p<0.0001).
- Source
- doi.org
- Type
- peer reviewed study
- Published
- 2020-03-01
- Retrieved
- 2026-08-27
- Verification
- unverified
- Confidence
- not stated
- Reviewer
- healthit-gate-v1
- Claim version
- v1
- Supports
- evidence_strength
- Score contribution
- Feeds evidence strength
Peer-reviewed. Check population, setting, and applicability to your workflow before generalizing.
Open doi.orgVerified provider experience is not yet publishable. Fewer than five independent provider organizations have contributed eligible reviews. Reviewer mode is off. Experience never changes documentary scoring, freshness, or rank.
Buyer lenses — evidence-backed bands at snapshot (not a 0–100 rank)
Deployment, integration, data handling at snapshot
- Integration maturity
- live — Listed on an EHR marketplace/partner program — live distribution.
- EHR path
- DICOM/PACS integration
- FHIR / API
- UNKNOWN
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- SSO
- UNKNOWN
Why unknown
Why. Single-sign-on support is not documented in vendor or marketplace materials on file.
What would close it. Vendor security documentation or marketplace listing mentioning SSO/SAML/OIDC.
- PHI / BAA
- Imaging under BAA for US deployments · BAA available
- Security attestations
- ISO 13485, CE MDR
- FDA status
- CLEARED
- Pricing
- Not publicly listed
Technical provenance
snap_36bba25c577cbb44 · Evidence cutoff: 2026-08-27T04:05Z · Snapshot generated: 2026-10-21T19:39Z · build ffbf5c3
Forecast calibration is not in the public snapshot — shown as UNKNOWN rather than read from SQLite.
Known limitations
- Deployment traction is UNKNOWN.
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.
- Economic value evidence is UNKNOWN.
Why unknown
Why. No independently verifiable ROI claim (peer-reviewed, audited case, or independent benchmark) is on file.
What would close it. An audited implementation report or peer-reviewed study with payback/throughput numbers.
- Market durability is UNKNOWN.
Why unknown
Why. No reliable source on file. The platform does not infer values from weak sources.
What would close it. A primary source or independent verification.