FDA Clears AI Software for CT Detection and Triage of Lower-Extremity Vascular Occlusion

FDA has cleared a CT-based AI tool for automated detection and triage of lower-extremity vascular occlusion. Exact manufacturer, predicate device, and performance metrics not reported in source.

• Device clearance (510(k) or PMA pathway not specified in source); targets CT imaging of peripheral arterial occlusion in the lower extremities.
• Intended use is detection and triage — suggesting a workflow-prioritization function similar to existing stroke/PE AI triage tools applied to peripheral vascular disease.
• No sensitivity, specificity, or AUC data reported in the available snippet; clinical validation details require review of the full FDA submission.

Automated summary

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