On June 22, 2026, Boston-based GuideAI Health Corp. announced that the U.S. Food and Drug Administration had granted 510(k) clearance for VascularAssist Occlusion Triage (VAOT), the company’s artificial intelligence software for prioritizing suspected vascular occlusion in the lower extremities.
VAOT is a Class II AI-based Software as a Medical Device that operates as a Computer-Aided Triage and Notification (CADt) device. It assists radiologists in identifying significant peripheral vascular disease, a leading contributor to acute and chronic limb ischemia, by flagging suspected occlusions on lower-extremity CT scans for prioritized review inside existing imaging workflows.
In the clinical performance testing that supported the clearance, the software achieved 95 percent patient-level sensitivity in 2D analysis and 94 percent in 3D analysis for identifying patients with peripheral artery disease, defined as having at least one lesion at 50 percent or greater stenosis.
The clearance extends the CADt triage category pioneered by stroke-detection tools into peripheral vascular disease, a condition that is frequently silent until it threatens the limb. It shows the FDA pathway for AI imaging triage continuing to broaden across specialties.