Deep Reasoning AI Secures FDA Clearance for NeuroDR

Deep Reasoning AI has won FDA 510(k) clearance for NeuroDR, software that strips bone, soft tissue and veins from a routine CT angiogram and automatically builds 3D views of the arteries that feed the brain — the first FDA-cleared product for a company founded by two Cornell University artificial-intelligence professors, cleared in roughly 105 days with help from a regulatory consultancy that says it skipped the usual pre-submission meeting.

Four views from one CT angiogram

NeuroDR takes a standard neck-to-brain CT angiogram, the scan already ordered when a clinician suspects a carotid or vertebral problem, and does the reconstruction work a technologist would otherwise build by hand. According to the companies’ 27 October 2026 announcement, the software removes bone, soft tissue and veins from the dataset, then automatically produces 3D maximum-intensity-projection views, 3D volume renderings and curved planar reformats of the left and right internal carotid and vertebral arteries, with anterior and posterior circulation shown separately so the two systems do not overlap. The finished images return to PACS as standard DICOM files, on the company’s account, without a radiologist or technologist selecting a protocol first.

Three things NeuroDR won’t do

01

Confirms, it doesn’t flag

NeuroDR’s cleared intended use is to help a physician confirm or rule out a lesion already identified, and to support evaluation, documentation, follow-up and treatment planning — not to detect or triage a scan on its own, the job most AI stroke-imaging tools are built around.

02

Zero-click by design

The software runs automatically once a CT angiogram finishes, without a technologist building the 3D reconstruction manually, and returns finished MIP, volume-rendered and curved-planar-reformat images directly to PACS.

03

A later entrant, not a first

NeuroDR joins an FDA-cleared field that already includes RapidAI’s Lumina 3D, cleared for head-and-neck CTA reconstruction in February 2025, and iSchemaView’s earlier Rapid CTA software. The clearance is new for Deep Reasoning AI; the underlying category is not.

NeuroDR, measured four ways

1stFDA-cleared product for Deep Reasoning AI, per CEO Mike Beck

105days from 510(k) submission to clearance, according to Innolitics

4arteries mapped per scan: left and right internal carotid and vertebral

3automated 3D view types per case: MIP, volume rendering, curved planar reformat

Figures from Deep Reasoning AI, Innolitics and 3DR Labs' 27 October 2026 clearance announcement, as carried by trade press. FDA's own public 510(k) record for the reported K262134 was not accessible to Regulatory News at publication; this page will be corrected if the official record differs.

The pre-submission meeting NeuroDR skipped

Deep Reasoning AI and Innolitics, the Austin, Texas regulatory consultancy that prepared and managed NeuroDR’s FDA submission, say the 510(k) cleared in roughly 105 days — fast enough, by Innolitics’ account, that the team skipped the optional pre-submission meeting most AI-imaging filings use to pressure-test FDA’s expectations beforehand, relying instead on experience from other cleared devices in the same product category. 3DR Labs, the Louisville, Kentucky medical-imaging post-processing company that says it is the largest such provider in the US, ran the performance studies behind the submission under a partnership with Deep Reasoning AI the two companies announced in August 2025.

What this article cannot independently confirm is the clearance’s official FDA record. Medical Device Network reports the 510(k) number as K262134; that number was not accessible to Regulatory News on FDA’s own 510(k) database as of publication, because this environment’s network access does not reach accessdata.fda.gov or api.fda.gov. The number is treated here as reported, not confirmed, and this page will be corrected if the official record differs.

“NeuroDR is Deep Reasoning AI’s first FDA-cleared product and a first step toward complete, patient-specific 3D anatomy from routine scans.” Mike Beck, President and Chief Executive Officer, Deep Reasoning AI — 27 October 2026 announcement

Two forecasts, a factor of five apart

How big a market NeuroDR is stepping into depends on whose stroke-AI forecast a reader trusts. MarketsandMarkets puts the global stroke AI market, which it defines to include imaging and workflow software, at $0.32 billion in 2025, reaching $1.60 billion by 2030. Roots Analysis, covering a similar space but a longer horizon, starts from $0.44 billion in 2026 and projects $8.05 billion by 2040. Regulatory News uses MarketsandMarkets’ nearer-term figures below as one consistent, citable baseline, not as a consensus the research itself lacks.

Stroke AI’s $1.3 billion disagreement

$0.32B → $1.60B

Global stroke AI market, 2025 to 2030, as forecast by MarketsandMarkets.

2025$0.32B

2030$1.60B

Sources: MarketsandMarkets, Stroke AI Market report · Roots Analysis, Stroke AI Market report

Regulatory News outlook

We expect NeuroDR to compete for a share of a stroke- and neurovascular-imaging AI market that its own forecasters have not agreed how to size, rather than to create a new category; 3DR Labs' existing hospital relationships likely matter more to its near-term reach than the published market figures do.

How we got here: MarketsandMarkets' published 38.4% compound annual growth rate on its $0.32 billion 2025 stroke-AI estimate reaches $1.60 billion by 2030. Roots Analysis's separate $0.44 billion 2026 estimate, growing to $8.05 billion by 2040, implies a roughly five-fold-larger addressable market over a longer horizon; we have not tried to reconcile the two methodologies and present both rather than pick one.

Three FDA-cleared ways to see a carotid on CT

Product	What it adds to a CTA read	US status	Maker
NeuroDR (Deep Reasoning AI)	Automatic 3D MIP, volume-rendered and curved-planar-reformat views of the carotid and vertebral arteries	FDA 510(k) cleared, Oct 2026 (K262134, reported)	Private
Lumina 3D (RapidAI)	Automated 3D reconstruction of head-and-neck CTA, including aortic arch and carotid tortuosity for access planning	FDA 510(k) cleared, Feb 2025	Private
Rapid CTA (iSchemaView / RapidAI)	3D imaging for CT angiography; an earlier generation of the same company's reconstruction software	FDA 510(k) cleared, 2018	Private

From each company's own FDA clearance records and public announcements; not a clinical comparison.

From a Cornell lab to a hospital PACS

NeuroDR did not start as a medical-device project. Deep Reasoning AI's own site traces the company to the research of its founders, Cornell University professors Bart Selman and Carla P. Gomes, on combining deep learning with structured, rule-based reasoning — work the pair published through Cornell as Deep Reasoning Networks. Turning that research into a cleared clinical product took a partner with imaging-industry distribution already in place.

Deep Reasoning AI's road to a first clearance

1. 2019

   Deep Reasoning AI founded

   Founded by Cornell University AI professors Bart Selman, PhD, and Carla P. Gomes, PhD. (Founding year per a third-party company database; Regulatory News could not independently confirm it against a company or regulatory filing.)

2. 26 August 2025

   3DR Labs partnership announced

   3DR Labs and Deep Reasoning AI announce a partnership to advance stroke risk assessment through AI-powered CTA analysis, pairing 3DR Labs' post-processing infrastructure with Deep Reasoning AI's algorithm — the work that becomes NeuroDR.

3. 27 October 2026

   FDA clears NeuroDR

   FDA grants 510(k) clearance for NeuroDR, Deep Reasoning AI's first cleared product, announced jointly with Innolitics and 3DR Labs after a roughly 105-day review.

4. Ahead

   US hospital rollout

   Deep Reasoning AI and 3DR Labs say they plan to bring NeuroDR to U.S. hospitals and imaging centers; neither company has published a launch date or pricing model.

Two partners, one commercial bet

A 510(k) clearance is a regulatory event, not a commercial one. Deep Reasoning AI has no other FDA-cleared product, no published accuracy or validation data for NeuroDR beyond the companies' own descriptive claims, and no disclosed pricing, reimbursement pathway or install base. Its route to hospitals runs through 3DR Labs, which supplies the post-processing relationships NeuroDR will need to reach radiology departments at scale — a dependence the two companies have been building since their August 2025 partnership, not one struck for this clearance alone.

• Clearance: FDA 510(k) for NeuroDR, announced 27 October 2026; reported as K262134 by trade press, not independently confirmed by Regulatory News on FDA's own database.
• Evidence: no sensitivity, specificity or validation-study figures have been published for NeuroDR by Deep Reasoning AI, Innolitics or 3DR Labs as of this article.
• Partners: Innolitics managed the FDA submission; 3DR Labs ran the performance studies and is named as the commercialization partner for US hospitals and imaging centers.
• Not yet public: a dedicated NeuroDR product page with full indications and limitations, a launch timeline, and pricing or reimbursement details.

Frequently asked questions

What did FDA actually clear for Deep Reasoning AI?

NeuroDR, software that strips bone, soft tissue and veins from a routine CT angiogram and automatically generates 3D maximum-intensity-projection views, volume renderings and curved planar reformats of the internal carotid and vertebral arteries, sent to PACS as DICOM images. Deep Reasoning AI and Innolitics announced the 510(k) clearance on 27 October 2026; trade press reported it the following day.

Does NeuroDR detect strokes or flag abnormal scans on its own?

No. Its cleared intended use is to help a physician confirm and evaluate a lesion already identified, and to support documentation, follow-up and treatment planning — not to detect, triage or flag findings independently, which is the job of a separate category of stroke-imaging AI tools.

Who else worked on NeuroDR, besides Deep Reasoning AI?

Innolitics, an Austin, Texas regulatory consultancy, prepared and managed the FDA submission, which the companies say cleared in roughly 105 days. 3DR Labs, a Louisville, Kentucky medical-imaging post-processing company that partnered with Deep Reasoning AI in August 2025, ran NeuroDR's performance studies and will help bring it to U.S. hospitals and imaging centers.

Is the 510(k) number K262134 confirmed?

It is reported by trade outlets including Medical Device Network, but Regulatory News could not independently open the record on FDA's own 510(k) database as of publication, because this environment's network access does not reach accessdata.fda.gov or api.fda.gov. Treat the number as reported, not yet independently verified; this page will be corrected if FDA's own record differs.

Is Deep Reasoning AI a public company?

No. It is privately held, based in Sarasota, Florida, and was founded by Cornell University AI professors Bart Selman, PhD, and Carla P. Gomes, PhD. NeuroDR is described by the company's CEO, Mike Beck, as its first FDA-cleared product.