GuideAI Health

Detection is the product and it operates on scans that already exist. The software applies AI models to lower extremity CT to identify suspected vascular occlusion and flag it for prioritized radiologist review, with the company's stated premise that early vascular changes are subtle, distributed, and easy to overlook even with modern imaging. There is no non AI version of finding a subtle stenosis pattern across a routine study.

The regulatory classification defines the oversight model precisely, which is why this grades well despite the company being early. It is cleared as a computer aided triage and notification device, meaning it reorders the radiologist's worklist rather than rendering a finding: it flags suspected cases for prioritized review inside existing imaging workflows. The radiologist still reads and diagnoses every study. Triage and notification is the most conservative category of imaging AI clearance, and choosing it rather than a detection claim is a deliberate scoping decision a buyer should understand as a feature.

Performance is published with the specificity the clearance required: 95 percent patient level sensitivity in 2D analysis and 94 percent in 3D analysis for identifying peripheral artery disease positive patients, with the positive definition stated explicitly as at least one lesion at 50 percent or greater stenosis. Publishing the case definition alongside the sensitivity figure is what makes the number interpretable. Specificity, model architecture, and validation cohort composition are not published.

Evidence today is the clinical performance testing submitted for clearance, which is real but narrow: sensitivity figures on identifying PAD positive patients, with no published prospective deployment data, reader study, or outcome evidence that earlier flagging changes time to intervention. The company's stated rationale, that peripheral vascular disease is too often missed or detected late with consequences up to limb loss, is clinically sound and widely accepted, but the link from triage flag to averted amputation is asserted rather than demonstrated. The company is very early, having received clearance in mid 2026.

No published PHI handling or data governance disclosure was located. The software processes CT imaging within radiology workflows, and no terms describing where inference runs or what is retained were found.

No HIPAA or BAA commitment was located in public materials, consistent with the company's very early commercial stage.

No SOC 2, ISO 27001, or equivalent attestation was located. FDA clearance addresses device safety and effectiveness and is not a substitute for information security attestation.

FDA 510(k) cleared as a Class II Software as a Medical Device, specifically as a computer aided triage and notification device for flagging suspected vascular occlusion on lower extremity CT, with supporting clinical performance data of 95 percent patient level sensitivity in 2D and 94 percent in 3D. For a company at this stage, holding a cleared product with a published performance basis and a precisely scoped indication is a strong position. Buyers should read the indication narrowly: it is triage of lower extremity CT for suspected occlusion, not general vascular assessment, and the company's broader vascular ambitions are not cleared.

No governance framework or bias evaluation was located. Peripheral artery disease prevalence and presentation differ meaningfully by diabetes status, race, and smoking history, and CT protocols vary by site, so subgroup performance is a live question that published materials do not address.

Designed to integrate into existing imaging workflows and radiology worklists rather than requiring a separate application, which is the necessary condition for a triage product to function at all. No named PACS integrations, standards support, or EHR connectivity were located.

No hosting, tenancy, or data residency disclosure was located.

No published pricing or commercial model. Worth noting for buyers that the company is publicly listed on a Canadian exchange while very early commercially, which means financial disclosures exist but tell you about the company rather than the cost of the product.

Narrow and precisely bounded: peripheral vascular disease detection on lower extremity CT within radiology workflows, targeted at patients at risk of acute or chronic limb ischemia. Buyers are radiology departments and imaging providers, with vascular surgery and podiatry as downstream referral beneficiaries. The company states a broader vision for AI driven vascular care, which should be read as roadmap rather than available capability.