Deep Reasoning AI and Innolitics Achieve FDA 510(k) Clearance for NeuroDR, AI Software for Neurovascular CT Angiography

Fully automated software turns head and neck CTA scans into 3D and curved planar views of the arteries that supply the brain, cleared 105 days after submission

SARASOTA, Fla. & AUSTIN, Texas--(BUSINESS WIRE)--Deep Reasoning AI Inc., a company founded by Cornell University artificial intelligence professors, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance (K262134) for NeuroDR, its AI-enabled software for visualizing the arteries of the head and neck from CT angiography (CTA) scans. NeuroDR was developed in collaboration with 3DR Labs, the largest provider of 3D medical image post-processing in the United States, which conducted the performance studies. Innolitics, the medical device software and regulatory consultancy, designed the studies, prepared the submission and managed the FDA review from regulatory strategy through clearance.

NeuroDR runs automatically in the background once a scan is complete. It removes bone, soft tissue and veins, then returns 3D maximum intensity projections, volume renderings, and curved planar reformats of the left and right internal carotid and vertebral arteries to the hospital's PACS as DICOM images. It also separates the anterior and posterior circulation into their own views, so physicians can review each without overlapping anatomy.

NeuroDR supports physicians in confirming the presence or absence of physician-identified lesions and in their evaluation, documentation, follow-up and treatment planning.

“NeuroDR is Deep Reasoning AI's first FDA-cleared product and a first step toward complete, patient-specific 3D anatomy from routine scans,” said Mike Beck, President and CEO of Deep Reasoning AI. “Innolitics guided us from strategy to clearance and answered every FDA question on a tight clock. We are ready to bring NeuroDR to hospitals.”

“Deep Reasoning AI brought rigorous AI software and a team willing to do the work FDA asks for,” said Yujan Shrestha, MD, Partner at Innolitics. “Clearing a fully automated neurovascular device 105 days after submission reflects that. We are proud to celebrate it with them.”

Innolitics knew FDA's expectations from similar cleared devices, so NeuroDR skipped the Pre-Submission meeting. Innolitics also wrote the software and cybersecurity documentation and led every FDA interaction, including an early orientation meeting with a live demo.

Deep Reasoning AI and 3DR Labs will bring NeuroDR to U.S. hospitals and imaging centers.

About Deep Reasoning AI

Deep Reasoning AI Inc. develops advanced AI technology for medical imaging that generates patient-specific 3D anatomical models directly from medical images. Its technology combines deep learning with reasoning based on anatomical knowledge, enabling models to remain robust in the presence of metal implants, imaging artifacts, anatomical variations and other challenging conditions. Its leadership includes Cornell University professors Bart Selman, PhD, and Carla P. Gomes, PhD. Learn more at deepreasoningai.com.

About 3DR Labs

3DR Labs transforms healthcare operations through a unified ecosystem of advanced medical imaging and intelligent automation. By integrating expert radiologic clinical services with a vendor-agnostic AI gateway and predictive workflow orchestration, 3DR harmonizes complex imaging and workflow analysis with human expertise.

This end-to-end innovation empowers providers to augment clinical expertise, automate workflows, and accelerate diagnostic interpretation. The result is a more efficient imaging enterprise that optimizes performance and reduces costs—ultimately driving faster, more efficient care delivery and improved patient outcomes across the entire continuum of care.

About Innolitics

Innolitics is a medical device software and regulatory consulting firm that offers everything needed to get an AI SaMD to market from concept to FDA clearance and beyond. Learn more at innolitics.com.