News & Media

News & Media

Company announcements, research highlights and demonstrations.

Company news · October 27, 2026

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.

Company news · October 20, 2026

3DR Labs Announces FDA Clearance of NeuroDR, a First-of-Its-Kind Neurovascular Imaging AI with Zero-Click Autonomous 3D Anatomical Modeling

3DR Labs and Deep Reasoning AI Inc. announce 510(k) clearance from the U.S. Food and Drug Administration for NeuroDR. NeuroDR is a first-of-its-kind, fully automated, AI-driven Software as a Medical Device (SaMD) designed for high-precision neurovascular 3D segmentation, anatomical modeling, and vessel centerlining.

FDA 510(k) clearance number K262134

Research & Media · June 19, 2025

Deep Reasoning AI and Mayo Clinic Partner to Advance Automated Spinal Bone Density Quantification in Journal of Clinical Medicine

Deep Reasoning AI Inc. and Mayo Clinic’s orthopedic research team, led by Dr. A. Noelle Larson, announced the publication of their collaborative study in the Journal of Clinical Medicine (JCM). The study validates Deep Reasoning AI’s spine model for fully automated 3D volumetric Hounsfield Unit (HU) quantification from lumbar CT scans in approximately 30 seconds per scan. The automated model demonstrated strong positive correlations, ρ up to 0.75, with gold-standard DXA metrics, offering a rapid, reproducible, and highly scalable solution for preoperative spine surgical planning and opportunistic osteoporosis screening.