FDA clears AI software that builds 3D views of brain arteries from CT scans

Overview

Updated 2 hours ago

A stroke patient's head CT used to wait on a technologist stripping away bone, soft tissue, and veins by hand before the arteries underneath could be read. The FDA cleared NeuroDR on October 7, software that automates that step and turns a CT angiography scan into clean 3D arterial views with no manual input.

The clearance, announced October 27, is Deep Reasoning AI's first. The company, founded by Cornell University AI professors, built the software with 3DR Labs, which calls itself the largest US 3D image post-processing provider and will sell NeuroDR to hospitals and imaging centers.

Why it matters

Manual post-processing delays stroke CT reads; NeuroDR automates it in minutes, potentially cutting time to treatment for stroke patients.

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Key Indicators

105 days

FDA review time, submission to clearance

From FDA receipt on June 25 to the decision on October 7, 2026.

20 weeks

Time from project kickoff to FDA submission

From the February 2 build start to the June 24 eSTAR filing.

Neurovascular pathways visualized

Left and right internal carotid and vertebral arteries, each with its own curved planar reformat.

K262134

FDA 510(k) number

Cleared under regulation 892.2050, product code QIH, radiology panel.

Voices

Curated perspectives — historical figures and your fellow readers.

People Involved

Mike Beck

President and Chief Executive Officer, Deep Reasoning AI

Leading NeuroDR's US commercialization with 3DR Labs

Jeanne Usonis

Applicant contact, Deep Reasoning AI

Named on the NeuroDR 510(k) submission

Cooper Molloy

Correspondent contact, Innolitics

Named on the NeuroDR 510(k) submission

Organizations Involved

Deep Reasoning AI, Inc.

AI software company

Developer of NeuroDR, its first FDA-cleared product

AI company founded by Cornell University professors that built NeuroDR and won its first FDA clearance.

Innolitics

Medical device regulatory consultancy

Prepared and managed NeuroDR's FDA submission

Austin-based consultancy that designed NeuroDR's performance studies and wrote its 510(k) submission.

3DR Labs

Medical image post-processing provider

Conducted NeuroDR performance studies; will commercialize the product

Largest provider of 3D medical image post-processing in the US, per the clearance announcement, and NeuroDR's commercialization partner.

U.S. Food and Drug Administration

Federal regulatory agency

Granted 510(k) clearance to NeuroDR

US Food and Drug Administration, which granted NeuroDR 510(k) clearance under regulation 892.2050.

Timeline

November 2025 October 2026

6 events Latest: 3 days ago

Tap a bar to jump to that date

October 2026
Companies announce the clearance
Latest Announcement

Deep Reasoning AI and Innolitics publicly announce the FDA clearance and US commercialization plans with 3DR Labs.
3 days ago
FDA grants clearance to NeuroDR
Regulatory

FDA finds NeuroDR substantially equivalent to the Rapid Neuro3D predicate, 105 days after submission.
October 7th, 2026
June 2026
FDA logs the NeuroDR submission
Submission

The agency formally records receipt of the application as 510(k) K262134.
June 25th, 2026
NeuroDR 510(k) submitted to FDA
Submission

Innolitics files the eSTAR application 20 weeks after kickoff.
June 24th, 2026
February 2026
510(k) build kicks off
Development

Innolitics and Deep Reasoning AI begin assembling the submission, including performance studies, software documentation, and cybersecurity files.
February 2nd, 2026
November 2025
Regulatory strategy phase begins
Strategy

Deep Reasoning AI and Innolitics map out the NeuroDR 510(k) strategy, skipping the FDA pre-submission meeting.
November 2025

Scenarios

NeuroDR reaches hospital radiology departments

Likely Resolves by Q2 2027

Discussed by: 3DR Labs and Deep Reasoning AI's commercialization plan, per the clearance announcement

3DR Labs, which calls itself the largest US 3D medical image post-processing provider, is the sales channel. If it lands NeuroDR in its hospital customer base and radiologists adopt the zero-click workflow, Deep Reasoning AI gains its first revenue and a repeatable case for broader 3D anatomy products.

Deep Reasoning AI pushes NeuroDR toward diagnostic claims

Possible Resolves by End of 2028

Discussed by: Company statements framing NeuroDR as a first step; Innolitics' account of FDA strategy

NeuroDR's cleared indication is visualization: helping physicians review lesions they have already identified, not detecting or diagnosing them. Seeking automated detection of stenosis, occlusion, or other findings would need new clinical studies and a fresh FDA review. The company has said NeuroDR is step one of a broader patient-specific anatomy platform.

Competitors copy NeuroDR's zero-click automation

Possible Resolves by End of 2027

Discussed by: The predicate Rapid Neuro3D already holds the same intended use; competitive pressure in radiology AI

NeuroDR's differentiators are full automation and separate views of the anterior and posterior brain circulations. Established players in CTA post-processing could add those features to their own cleared products, eroding NeuroDR's edge before it builds market share.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

February 2018

Viz.ai ContaCT (2018)

Viz.ai became one of the first companies the FDA cleared for automated stroke imaging. Its software flags suspected large vessel occlusions on CT angiography scans and alerts stroke teams in real time, under a De Novo authorization.

Then

Stroke teams began receiving automatic pages when scans showed a blockage, cutting the time between scan and treatment decision.

Now

The clearance established a template for how the FDA reviews AI that moves beyond image display into active triage.

Why this matters now

Viz.ai proved AI could change stroke workflow, the same territory NeuroDR's zero-click automated post-processing now enters.

2024

Rapid Neuro3D (2024)

3DR Labs' Rapid Neuro3D, cleared under 510(k) K243350, automated neurovascular CTA post-processing with the same intended use as NeuroDR. It is the predicate device NeuroDR was compared against.

Then

The clearance set performance benchmarks for automated CTA visualization products.

Now

New devices like NeuroDR can lean on its published performance to set acceptance criteria, shortening FDA review.

Why this matters now

NeuroDR used Rapid Neuro3D as its predicate, adding separate views of the anterior and posterior circulations as a visualization difference that raised no new safety questions.