Deep Reasoning AI and Innolitics Achieve FDA 510(k) Clearance for NeuroDR, AI Software for Neurovascular CT Angiography
Deep Reasoning AI Inc. and Innolitics announce 510(k) clearance (K262134) from the U.S. Food and Drug Administration for NeuroDR, AI-enabled software that visualizes the arteries of the head and neck from CT angiography (CTA) scans. The software automatically removes bone and soft tissue to generate 3D volume renderings and separate anterior and posterior circulation views for clinical review. Together, we successfully cleared the FDA submission in just 105 days.