GuideAI Health

What are the scope and limits?

The 510(k) text covers "the analysis of CTA studies of adult patients" for workflow prioritization of studies with imaging patterns consistent with possible total arterial occlusion in the aorta, common iliac, external iliac, common femoral, superficial femoral and popliteal arteries. It also says the software "does not detect, localize, characterize, measure, or diagnose vascular disease". FDA used Aidoc's BriefCase LVO Triage (K220709, head CTA) as the primary predicate, and the difference is the lower extremity territory.

GuideAI's website talks about finding peripheral artery disease in imaging taken for other reasons. Plaque quantification, longitudinal monitoring, carotid and coronary modules, a workflow platform in pilot design and Executive Health arterial characterization are described as investigational. A Gateway component acts as a PACS listener, receives a copy of the CTA DICOM study and alerts the PACS or RIS workstation, and the vendor says it adds no new viewer or parallel queue.

What did the sponsor's test measure?

The 510(k) summary reports a standalone premarket validation that the sponsor ran. Sensitivity was 0.915 (95% CI 0.862 to 0.953) and specificity 0.901 (0.842 to 0.944), against a primary endpoint goal of 80%, and the secondary endpoint of notification in under 5 minutes was met. The website claims above 90% sensitivity at patient level. The study data is the sponsor's premarket test, and PubMed lists no paper on the product.

Who backs it and how is it sold?

Two interventional radiologists founded the company, Dr. Raj Shah as CEO and Dr. Luke Higgins as CMO and COO. The vendor describes a model development agreement with vRad, with access to imaging from more than 2,100 hospitals. After a business combination in June 2026 the shares trade on Cboe Canada as GDAI. FDA lists the applicant in Boston, Massachusetts, and the website states no headquarters.

For hospitals and practices the home page describes a platform fee plus a per study component, and amounts are not published.

The verdict

VAOT fits an imaging service with steady lower body CTA volume that wants a worklist flag for possible total occlusion. It does not fit a buyer who needs a diagnostic read or broader peripheral artery disease detection. The 0.915 sensitivity comes from the vendor's own premarket test.