NeuroDR FDA clearance: AI CT angiography software in 105 days
The NeuroDR FDA clearance, announced by Deep Reasoning AI and Innolitics on October 27, 2026, allows the Sarasota company to market AI software that removes bone and soft tissue from head and neck CT angiography scans and produces 3D views of the arteries. The companies say the 510(k) review took 105 days. For imaging providers, it automates a routine step before a scan is read; for AI device makers, it shows a fast path through the FDA.
What task NeuroDR takes off a radiology team's hands
NeuroDR prepares head and neck CT angiography scans for review by stripping away everything but the arteries. In a CTA scan, the vessels sit among bone and soft tissue, and that material has to be removed before a clinician can study the arteries in 3D. Deep Reasoning AI says NeuroDR removes bone and soft tissue automatically and produces 3D volume renderings, with separate views of the anterior and posterior circulation for clinical review.
Deep Reasoning AI, based in Sarasota, Florida, has aimed this work at stroke. In August 2025 it partnered with 3DR Labs to advance stroke risk assessment through AI-powered CTA analysis, combining its AI with 3DR Labs' image post-processing expertise in automated segmentation and vessel centerlining.
What the FDA cleared, and under which rules
The FDA cleared NeuroDR under 510(k) number K262134. The agency's database lists it as Automated Radiological Image Processing Software, product code QIH, under regulation number 892.2050, reviewed by the radiology panel. The FDA found the device substantially equivalent to devices already on the market.
The submission was a traditional 510(k), received on June 25, 2026, with a decision dated October 7, 2026. It was not reviewed by a third party, and it does not include an authorized predetermined change control plan.
How the software works on a CT angiography scan
The software runs without manual steps. 3DR Labs, which announced the clearance on October 20, 2026, describes NeuroDR as fully automated software as a medical device for neurovascular 3D segmentation, anatomical modeling and vessel centerlining, with what it calls zero-click autonomous 3D anatomical modeling. 3DR Labs also calls it first of its kind; that is the company's description, not an FDA finding.
In practice, the output is a set of 3D images of the head and neck arteries, already cleaned of bone and tissue, that a clinician reviews.
How the NeuroDR FDA clearance came in 105 days
The companies say the review took 105 days. Deep Reasoning AI filed with Innolitics, an Austin, Texas firm listed by the FDA as the correspondent on the submission, and the two announced the clearance on October 27, 2026.
"Together, we successfully cleared the FDA submission in just 105 days." — Deep Reasoning AI and Innolitics, announcing the clearance
Deep Reasoning AI has also drawn federal research money. In May 2025 it received an NIH grant of $350,000, with Mayo Clinic, to develop 3D anatomical modeling and virtual surgical planning for craniomaxillofacial reconstruction.
What the clearance means for imaging providers and AI device makers
For hospitals, imaging centers and 3D labs, the value is in the preparation step. Separating vessels from bone is routine work that comes before any reading, and NeuroDR is cleared to do it automatically. The companies have not published figures on time saved per scan, so the gain for a given site is not yet measured.
For AI device makers, the case shows a practical route to market: a narrow, well-defined imaging task, an existing product code and a regulatory partner handling the submission. Deep Reasoning AI reached clearance in 105 days by its own count, with a specialist firm as correspondent on the filing.
Questions and answers
What is NeuroDR?
NeuroDR is AI software from Deep Reasoning AI that visualizes the arteries of the head and neck from CT angiography scans. It removes bone and soft tissue automatically and generates 3D volume renderings for clinical review.
When did NeuroDR receive FDA clearance?
The FDA decision is dated October 7, 2026, under 510(k) number K262134. The FDA received the submission on June 25, 2026, and the companies say it was cleared in 105 days.
Who helped Deep Reasoning AI with the FDA submission?
Innolitics, listed by the FDA as the correspondent on the submission. 3DR Labs, Deep Reasoning AI's partner on CTA analysis since August 2025, also announced the clearance.
MOZGII view
How we would build it
Software that cleans up CT angiography scans sits early in the stroke workflow, before any diagnosis. That is a sensible place for AI in medicine. The task is repetitive, the output is an image a specialist still reads, and a mistake is visible on screen rather than hidden in a score.
For a tool of this kind, we would start with the scans: thousands of head and neck CTA studies from different scanner makers, contrast timings and patient groups, each with expert-checked outlines of the vessels. The model would separate bone from arteries and draw each vessel's centerline. A radiologist or 3D lab technician would review every output at first and flag cases where a vessel was cut off or bone was left in. Those flags would become the test set that every new model version must pass.
The weak spot is the unusual case: metal implants, a calcified artery close to bone, motion during the scan. The tool would need to say when it is unsure and pass the study back to a person instead of returning a clean picture that hides a missing vessel.
The one metric we would watch is the share of studies a clinician accepts without manual correction. Next, we would add a change control plan to the FDA file, so improved models could ship without a new review each time.
Sources
Where the facts in this story come from.