FDA Clears Deep Reasoning AI's NeuroDR Software for Neurovascular CT Angiography

Deep Reasoning AI has received FDA 510(k) clearance for NeuroDR, software that automatically produces 3D views of the arteries of the head and neck from CT angiography (CTA) scans, the company and its regulatory partner Innolitics said on October 27 in a Business Wire release, as republished by 01net. The company said NeuroDR is its first FDA-cleared product.

The FDA's 510(k) database lists NeuroDR under K262134, with Deep Reasoning AI of Sarasota, Florida, as the applicant. The entry shows the submission was received on June 25, 2026, and a substantial equivalence decision on October 7. The device falls under product code QIH, automated radiological image processing software, and regulation 892.2050.

What the software does

According to the release, NeuroDR runs automatically in the background once a scan is complete. It removes bone, soft tissue and veins and sends the processed images to the hospital's picture archiving and communication system (PACS) as DICOM files, with the anterior and posterior circulation shown in separate views.

AuntMinnie reported that the outputs include 3D maximum intensity projections, volume renderings and curved planar reformats of the left and right internal carotid and vertebral arteries, and that showing the two circulations separately is meant to avoid overlapping anatomy.

The companies said the software is intended to help physicians confirm or rule out lesions they have identified and to support evaluation, documentation, follow-up and treatment planning. The release does not describe it as detecting or diagnosing disease on its own.

Who did what

NeuroDR was co-developed with 3DR Labs, a provider of 3D medical image post-processing, which ran the performance studies, according to the release. Innolitics designed the studies, prepared the submission, wrote the software and cybersecurity documentation and managed the FDA review. The companies said they skipped a Pre-Submission meeting with the agency and that the FDA cleared the device 105 days after submission.

Medical Device Network reported that Innolitics gave a live demonstration at an early orientation meeting with the FDA, and that the team skipped the formal Pre-Submission because it already understood the agency's expectations from earlier clearances of similar devices. Beck said in the release that Innolitics "answered every FDA question on a tight clock."

Deep Reasoning AI was founded by Cornell University AI professors, including Bart Selman and Carla P. Gomes, according to the release. Medical Device Network reported that the company combines deep learning with anatomical reasoning to build patient-specific 3D models, including when scans contain anatomical variation, imaging artifacts or metal implants. Beck called NeuroDR "a first step toward complete, patient-specific 3D anatomy from routine scans," according to that report.

"We are ready to bring NeuroDR to hospitals," said Mike Beck, the company's president and chief executive. The companies said they plan to bring NeuroDR to US hospitals and imaging centers with 3DR Labs. They did not disclose pricing or validation results in the release.