FDA Clears CT-Based AI Software for Detection and Triage of Vascular Occlusion in Lower Extremities

The Food and Drug Administration (FDA) has granted 510(k) clearance for the VascularAssist Occlusion Triage (VAOT) software, a CT-based AI software that may facilitate more timely detection and triage for patients with peripheral artery disease (PAD).

The VascularAssist Occlusion Triage software flags possible cases involving vascular occlusion and facilitates prioritized radiologist review of the cases within radiology workflows, according to GuideAI Health, the developer of the software.

In clinical performance testing, GuideAI Health pointed out that the VascularAssist Occlusion Triage software provided a 95 percent patient-level sensitivity for 2D CT analysis and a 94 percent sensitivity in 3D CT evaluation.

"Peripheral vascular disease is too often missed or detected late, with devastating consequences. VAOT brings AI-powered triage directly into the radiology workflow, helping clinicians identify vascular disease sooner so patients can be directed to the right care faster. This clearance marks the first step in our broader vision to set a new standard in AI-driven vascular care,” noted Raj Shah, MD, MBA, the chief executive officer of GuideAI Health.