Sarasota, FL-based Deep Reasoning AI has received U.S. Food and Drug Administration (FDA) 510(k) clearance for NeuroDR, its software for visualizing the arteries of the head and neck on CT angiography (CTA) scans.
NeuroDR runs automatically once a scan is complete, according to the firm. It removes bone, soft tissue, and veins, and then sends 3D maximum intensity projections, volume renderings, and curved planar reformats of the left and right internal carotid and vertebral arteries to PACS as DICOM images. It also displays the anterior and posterior circulation in separate views so they can be reviewed without overlapping anatomy. The software is intended to help physicians confirm and evaluate lesions they have identified, and to support documentation, follow-up, and treatment planning, the company said.
Deep Reasoning AI developed NeuroDR with 3D post-processing provider 3DR Labs, which conducted the performance studies, while Innolitics prepared the submission and managed the FDA review, Deep Reasoning AI noted.
