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Found late
PAD is typically detected once symptoms have appeared and damage has occurred. The early changes are subtle and routinely overlooked in studies acquired for another indication.
FDA 510(k) cleared · VascularAssist™ Occlusion Triage
Illustrative screen capture of the GuideAI Health viewer. Segment-level stenosis quantification and plaque characterisation shown here are investigational, are not cleared by the FDA, and are outside the VascularAssist™ Occlusion Triage clearance for triage and notification.
The gap
Vascular disease writes itself into scans taken for entirely different reasons. The signal is there — subtle, distributed across dozens of segments, and easy to pass over in a high-volume list.
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PAD is typically detected once symptoms have appeared and damage has occurred. The early changes are subtle and routinely overlooked in studies acquired for another indication.
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Imaging produces enormous volume, but early vascular risk stays unresolved. The gap is not access to data — it is the distance between the data and something a clinician can act on.
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Late detection removes the preventive window. What is left is intervention, higher event rates, and in the worst outcomes, limb loss.
What we build
Cleared · In market
Deep-learning analysis built by interventional radiologists to reflect how a vascular read is actually performed — segment by segment, rather than as a whole-study impression. VAOT is FDA 510(k) cleared for triage and notification of suspected peripheral arterial occlusion, and reported up to 95% patient-level sensitivity in validation.
It sits inside the existing radiology workflow. No new viewer, no parallel queue, no change to how a study is acquired.
The platform →In development · Investigational
A detection that never reaches the patient changes nothing. Elevate is a clinical workflow layer designed to convert an imaging finding into coordinated, longitudinal care — capture the finding, standardise it into a clinical signal, route the patient to the right next step, and track what happened.
Designed around peripheral arterial, carotid and coronary disease, and currently in pilot design with health system partners.
How Elevate works →Our position on clearance
We completed FDA 510(k) review so that our customers don’t have to carry that validation risk themselves.
Clearance is a floor, not a closing argument
Where we work
The model is one thing. The route to the patient is five — and each one has a different buyer, a different economic shape, and a different definition of proof.
A novel component of the executive physical
Executive health programmes have spent a decade refining how they estimate cardiovascular risk. GuideAI Health offers something different in kind: a direct look at the arterial tree from the mid-abdomen to the ankle, characterised segment by segment, in a scan the programme is often already taking.
The executive health programme →Standing behind it
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Founded by interventional radiologists after seeing early PAD signs repeatedly missed in routine imaging.
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510(k) clearance granted June 2026 for the VAOT triage and notification indication. We name the indication and stop there.
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Company to Watch at the LSI Emerging Medtech Summit; featured in Canada’s Drug Agency Horizon Scan.
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Clinical advisory including Dr. James Benenati, interventional radiologist and Chief Medical Officer of Penumbra, Inc.
On language. VascularAssist™ Occlusion Triage is FDA cleared through the 510(k) pathway for triage and notification. Clearance rests on substantial equivalence to a legally marketed predicate device — it is not a finding of clinical superiority, and we do not present it as one.
A structured evaluation on your imaging, with agreed success metrics before we start. We will tell you plainly if the economics do not work at your site.