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

Engineered in partnership with Deep Reasoning AI, NeuroDR delivers autonomous, real-world 3D neurovascular centerlining and reconstructions in minutes to accelerate stroke and surgical decision-making.

LOUISVILLE, KY – 3DR® Labs, together with its partner Deep Reasoning AI Inc. (Deep Reasoning AI), today announce 510(k) clearance from the U.S. Food and Drug Administration (FDA) 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.

While conventional AI imaging solutions stop at initial triage and alerting, NeuroDR provides the critical next step. Built on Deep Reasoning’s technology, NeuroDR transforms raw CT Angiography (CTA) DICOM data - from the aortic arch to the vertex of the head into high-fidelity, diagnostic-ready 3D anatomical models within minutes of processing time without human intervention.

“Where current AI triage tools simply flag a potential anomaly, NeuroDR provides the deep anatomical clarity clinicians need to actively plan interventions,” said Mike Beck, CEO at Deep Reasoning. “By automating complex post-processing entirely in the background, we are eliminating manual editing bottlenecks and delivering comprehensive, diagnostic-ready anatomical models directly to PACS at point-of-care speeds.”

Key features and benefits of the NeuroDR platform include:

• Zero-Click Autonomous Workflow: Operates seamlessly as a background post-processing SaMD, automatically ingesting head and neck CTA DICOM scans and delivering maximum intensity projections (MIP), volume renderings (VR), and curved planar reformats (CPR) directly back to PACS with zero manual technologist clicks.

• Unified Neurovascular Coverage: The industry's first automated platform to provide simultaneous 3D visualization of both the anterior and posterior circulations in a single, unified workflow, removing the need for clinicians to bridge fragmented single-vessel datasets.

• Accelerated Turnaround & Efficiency: Reduces 3D post-processing turnaround times from several hours to just a few minutes, increasing scanner throughput and eliminating technologist editing time across these clinical protocols.

• Real-World Reliability: NeuroDR is specifically trained on diverse real-world CTA cases with reasoning guided by prior anatomical knowledge to maintain high first-pass accuracy, even on challenging scans containing artifacts or sub-optimal contrast.

  
  

“Our collaboration with Deep Reasoning allows us to bridge advanced AI research and high-demand clinical workflows,” said Mike Jackman, CEO of 3DR Labs. “NeuroDR provides healthcare systems with a scalable solution that reduces technician workload, optimizes 3D lab operations, and ensures immediate access to precise anatomical models when every minute counts.”

3DR Labs will showcase live interactive demonstrations of NeuroDR at the upcoming Radiological Society of North America (RSNA) 2026 Annual Meeting in Chicago, IL. Attendees, radiologists, and imaging leaders are invited to visit 3DR Labs at Booth #4961 to experience zero-click, real-time 3D reconstructions.

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 Deep Reasoning

Deep Reasoning AI Inc. develops advanced AI technology for medical imaging that generates patient-specific 3D anatomical models directly from CT, CTA, X-ray and other 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. This knowledge-driven approach also enables the rapid development of new AI models using limited labelled training data.

Media Contact: Elizabeth Morgan Marketing Manager 3DR Labs