Detection is half of it. The other half is what happens next.

VascularAssist™ finds the disease. Elevate makes sure the finding becomes care. Two layers, built to sit inside the systems a health system already runs.

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Layer one · Cleared

VascularAssist™ Occlusion Triage

FDA 510(k) cleared for triage and notification of suspected peripheral arterial occlusion. Up to 95% patient-level sensitivity reported in validation.

Curated foundation

Developed on high-quality curated imaging drawn from more than 2,100 hospitals — breadth of scanner, protocol and population, not a single-site cohort.

Deployed either way

Cloud or on-premises, with integration designed to be frictionless against existing PACS and reporting infrastructure.

Reads like a radiologist

The architecture follows how a vascular read is actually performed — territory by territory — rather than producing a whole-study classification.

Structured output

Consistent, structured reporting that reduces interpretive variability between readers and between studies.

Structured output · schematic

What it changes on a Tuesday.

Outcomes. Earlier identification creates a preventive window — the difference between managing disease and responding to an event, including limb loss.

Consistency. The same study read twice produces the same structure, which is what makes comparison over time meaningful.

Efficiency. A force multiplier on high-volume worklists, prioritising the studies that warrant attention rather than adding a queue.

Coordination. Earlier detection gives the downstream service line time to act, instead of inheriting a patient who has already progressed.

Lower-limb CT angiogram with the arterial tree highlighted

What it reads

The study is already on the system.

Cross-sectional imaging taken for something else routinely covers the aorto-iliac and infra-inguinal vessels. VascularAssist™ reads that coverage for occlusive disease rather than asking for a new acquisition.

Illustrative angiographic rendering, not output of the cleared device.

The viewer

Segment navigation and cross-sectional review

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.

Layer two · In development

Elevate

A clinical workflow platform that converts imaging findings into coordinated, longitudinal patient care.

The gap Elevate addresses

— Imaging findings stay siloed across departments.

— Follow-up is inconsistent, or missed outright.

— Coordination breaks between radiology, primary care and specialty services.

AI has improved detection considerably. It has not, on its own, improved what happens after the detection — and that is where the outcome is actually determined.

01CaptureIdentify the clinically significant finding wherever it surfaces.

02StandardiseConvert model output into a consistent, actionable clinical signal.

03RouteDirect the patient to the appropriate next step, with the right service line.

04TrackFollow the patient longitudinally and measure whether the step happened.

Disease programmes in scope

Peripheral arterial disease	The founding indication. Detection, characterisation and longitudinal follow-up.
Carotid disease	Second module in development; CarotidAssist clearance targeted for Q1 2027.
Coronary artery disease	In programme design, on the same capture–standardise–route–track structure.

Status. Elevate is in development and is currently being designed with health system partners for clinical pilots. It is not cleared by the FDA. Only VascularAssist™ Occlusion Triage, for the triage and notification indication, holds 510(k) clearance.

Regulatory status

What is cleared, and what is not.

Module	Intended use	Status
VascularAssist™ Occlusion Triage	Triage and notification of suspected peripheral arterial occlusion. Adjunct to the standard of care; not for primary diagnostic interpretation.	FDA 510(k) cleared — June 2026
Quantified stenosis & plaque burden	Segment-level quantification and plaque characterisation.	Investigational — not cleared
CarotidAssist	Carotid disease detection.	In development — clearance targeted Q1 2027
Elevate	Clinical workflow, routing and longitudinal tracking.	In development — not cleared

Cleared, not approved. GuideAI Health’s device was reviewed under the FDA 510(k) pathway, which is granted on the basis of substantial equivalence to a legally marketed predicate device. It is not a PMA approval and it is not a finding of clinical superiority. We describe it as cleared, for a named indication, and make no claim beyond that indication.

Integration & assurance

Built to pass the review, not just the demo.

Deployment	Cloud or on-premises, to suit the institution’s data posture
Workflow	Into existing PACS and reporting infrastructure — no parallel viewer
Data handling	HIPAA documentation and Business Associate Agreement available
Diligence pack	Security questionnaire responses, model and data governance documentation on request

Evaluate it on your own studies.

A time-boxed evaluation with agreed success metrics, run on your imaging, before anyone signs anything.

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