AI-Rad Companion Brain MR

Evidence summary

VA60 WMH testing used 100 subjects and follow-up testing used 165 subjects, with manually annotated reference data. Morphometry and morphometry follow-up were unchanged from the predicate. Testing supports the modified quantitative features, not a new prospective outcome benefit.

FDA source Exact FDA submission Checked 2026-09-06

Preserves the baseline 100-subject cohort and adds the separately described 165-subject follow-up cohort; these are not pooled as unique patients.

• 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 2026-09-06

Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

• Verify security and privacy controls: Exact-release data flows, hosting region, retention and scoped dated security certification remain unresolved; regulatory software testing is not current operational assurance.
• Verify training: A predecessor data sheet is available, but exact VA60 onboarding, competency and support terms were not verified.
• Verify pricing and total cost: VA60 module, cloud/edge infrastructure, PACS integration and service prices are not established from reviewed materials.
• Verify reimbursement and coding relevance: No applicable payer coverage/payment policy reviewed for automated brain volumetry or WMH quantification.
• Verify local validation and lifecycle monitoring: Processing-status notifications in predecessor documentation do not establish clinical drift monitoring for VA60.
• Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

Stored metadata screened September 5. Primary author-institution abstract reviewed September 6 after PubMed/PMC verification barriers; retained as 45-participant family volumetry study, not VA60 results. Stored trial array was empty. The current discovery snapshot contains 1 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, acr ai central product, fda decision summary, vendor technical documentation, peer reviewed literature, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall

• AI-Rad Companion Brain MR VA60: K253057 clearance and summary U.S. Food and Drug Administration · 2026-09-06
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• AI-Rad Companion Brain MR model card (K253057) 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
• AI-Rad Companion Brain MR VA51 data sheet, valid January 2025 Siemens Healthineers Academy · 2026-09-06
• Validity Assessment of an Automated Brain Morphometry Tool for Patients with De Novo Memory Symptoms American Journal of Neuroradiology / Washington University Research Profiles · 2026-09-06