Episode Details

We unpack the FDA 510(k) summary for Aidoc's BriefCase-Triage, a cloud-based AI tool cleared in May 2026. Listeners will learn how it performs in flagging large and medium vessel occlusions, the real numbers behind its 1.09-minute notification time, and the specifics of its multicenter retrospective testing.

Key points

• BriefCase-Triage is a cloud-based, linux-server AI software that flags suspected large and medium vessel occlusions on CTA and mCTA images.
• The clearance expands upon a predicate device (K220709) by adding mCTA acquisition protocols to the inclusion criteria.
• In a retrospective, blinded, multicenter study, the software showed a sensitivity of 81.4% and a specificity of 85.5%.
• The positive predictive value was 38.4%, while the negative predictive value was 97.6%.
• Time-to-notification was registered at 1.09 minutes, compared to 2.23 minutes for the predicate device.
• The AI operates in parallel with the standard of care, providing low-quality, grayscale preview images meant only for prioritization, not primary diagnosis.

Source: FDA 510(k) summary K261317: BriefCase-Triage (Aidoc) - U.S. Food and Drug Administration, 2026

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-aidoc-briefcase-triage-triage-time-cut-to-1-09-minut-176e60