Genius AI Detection 2.0

Evidence summary

Retrospective multicenter validation included 1,475 subjects from 15 locations with biopsy-proven cancers, benign cases, screening-negative cases, and diagnostic cases; the FDA packet reports no significant ENV-SOC versus ENV-ECS reader-study AUC difference.

FDA source Exact FDA submission Checked 2026-09-06

• Source

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify security and privacy controls: No scoped current security or data-flow documentation was established.
• Verify training: Current onboarding, competency, and support commitments were not established.
• Verify pricing and total cost: No public amount, range, currency, geography, or contract term was established.
• Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
• Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, update control, and drift review were not established.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

No stored PubMed or ClinicalTrials.gov candidate identifiers for this submission in the 2026-09-01 snapshot; exact-submission recall candidate review was also zero. This metadata screen is not a full paper review. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) K243341: Genius AI Detection 2.0 U.S. Food and Drug Administration · 2026-09-06
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Genius AI Detection 2.0 model card (K243341) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Genius AI Detection technology official product page Hologic · 2026-09-07