ScreenDx

Evidence summary

Retrospective multicenter pivotal study of 3,018 unique patients, enriched to 23% positive lung-fibrosis diagnoses, using independently recorded clinical diagnoses as reference. The baseline reports sensitivity 91.4% and specificity 95.2%; an additional 2,482-case low-prevalence dataset is separately described in the FDA summary.

FDA source Exact FDA submission Checked 2026-09-05

Regulatory study context; no independent efficacy or referral-outcome claim.

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

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 deployment and data flow: FDA describes APIs and an ingestion/analysis system but does not establish the current customer's hosting topology, region, or retention terms.
• Verify security and privacy controls: No dated, scoped commercial security attestation was reviewed. Data transfer, storage, deletion, access control, and incident-response terms remain to be obtained.
• Verify training: The vendor describes background automation, but clinician training and referral-ownership onboarding commitments were not established.
• Verify pricing and total cost: The reviewed official ScreenDx page requests contact and does not specify a scoped price. Confirm per-case or enterprise terms, integration, minimum volume, and support; procurement research is incomplete.
• Verify reimbursement and coding relevance: No applicable payer policy was reviewed; Fibresolve or underlying CT payment cannot establish ScreenDx reimbursement.
• 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.

Stored metadata for all three papers screened. PMID 40020875 abstract and disclosures support a product-family contextual study; exact build linkage is unresolved. PMID 37822853 and PMID 41314436 are relevant pulmonary-fibrosis/ILD leads but full methods/version linkage were not reviewed and no results were promoted. No stored trial candidates. The current discovery snapshot contains 3 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, fda decision material, vendor product page, literature index, peer reviewed literature, trial registry, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) K241891: ScreenDx U.S. Food and Drug Administration · 2026-09-05
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• ScreenDx model card (K241891) 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
• ScreenDx official product and clinical-validation page IMVARIA · 2026-09-05
• ScreenDx, an artificial intelligence-based algorithm for the incidental detection of pulmonary fibrosis The American Journal of the Medical Sciences; abstract via PubMed · 2026-09-05