Boston-based AI start-up GuideAI Health has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for software designed to identify peripheral vascular disease in the lower extremities.
VascularAssist Occlusion Triage is an AI-based computer-aided triage software that flags suspected vascular occlusion on CT scans for prioritized radiologist review within existing imaging workflows, the company said. In clinical performance testing supporting the clearance, the software achieved 95% patient-level sensitivity in 2D analysis and 94% in 3D analysis for identifying peripheral artery disease-positive patients, defined as those with at least one lesion at 50% or greater stenosis, according to the company.
By flagging high-priority cases earlier, the software can help reduce the time to diagnosis and intervention for patients at risk of limb-threatening disease, GuideAI said.
![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
