Regulatory. VascularAssist™ Occlusion Triage (VAOT) is FDA 510(k) cleared for triage and notification of suspected peripheral arterial occlusion. It is an adjunct to, and not a replacement for, the standard of care or clinician judgement, and is not intended for primary diagnostic interpretation. Capabilities described elsewhere on this site — including quantified plaque burden, plaque composition, longitudinal monitoring, carotid and coronary modules and the Elevate platform — are in development or investigational and are not cleared by the FDA. GuideAI Health’s device is cleared under the 510(k) pathway; it is not “FDA approved.”
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