FDA Clears GuideAI Health’s AI-Powered Vascular Occlusion Triage Software

FDA 510(k) clears GuideAI Health's Vascular Assist Occlusion Triage (VAOT), an AI-powered radiology tool for detecting vascular occlusion on imaging (product code QAS).

• VAOT is a computer-assisted triage software cleared under FDA product code QAS (radiological CAD).
• The clearance summary does not report clinical performance metrics, intended imaging modality, or anatomical region.
• Device clearance does not imply prospective validation or proven clinical impact.

RadPigeon summaries are original and for information only. They are not clinical advice.