Company Spotlight: GuideAI VAOT - Triage AI for Peripheral Arteries

We unpack the FDA 510(k) summary for GuideAI's Vascular Assist Occlusion Triage (VAOT) software. We explore its clinical targets in the lower extremities, the technical workflow, and how it achieved clearance using a stroke-triage AI as its predicate device.

Key points

• GuideAI's VAOT is a Class II triage tool for detecting total arterial occlusion in the lower extremities, achieving a sensitivity of 0.915.
• The software operates entirely in parallel with standard-of-care, sending notifications via DICOM Secondary Captures.
• VAOT secured FDA clearance by demonstrating substantial equivalence to Aidoc's Briefcase LVO Triage, a device used for stroke detection in the brain.
• Performance testing was retrospective, using a 317-case dataset enriched with 21 positive aortic occlusions.

Source: FDA 510(k) summary K260729: Vascular Assist Occlusion Triage (VAOT) (v1.0) (GuideAI Health) - 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.

Company: GuideAI Health (guideaihealth.com) · Product: Vascular Assist Occlusion Triage (VAOT) (v1.0) · FDA 510(k) K260729

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-guideai-vaot-triage-ai-for-peripheral-arteries-a66eea