The FDA has cleared new brain aneurysm AI software for use on head CT angiography scans. Bracco and Avicenna.AI announced the 510(k) clearance on November 13, 2026. The product is called UPTUNITY | Aneurysm. It is meant to help radiologists notice suspected aneurysms and track known ones over time.
Here is what we verified. The FDA’s public database lists the first clearance, K262062, for a device named CINA-Aneurysm. Its decision date is October 20, 2026. The companies, plus two trade outlets, describe what the software does. What we could not find is any published accuracy data.
What the FDA Cleared
According to the companies’ release, two versions received 510(k) clearance. UPTUNITY | Aneurysm Detection maps to K262062. UPTUNITY | Aneurysm Management maps to K262147. We confirmed K262062 in the FDA database. We saw K262147 only in the release.
A 510(k) clearance means the FDA found a device substantially equivalent to one already on the market. It is not the same as a full approval. It also says nothing, on its own, about how well the software performs for any one patient.
What the Software Does on a Scan
The detection version is computer-assisted detection and diagnosis software. AuntMinnie reports it is meant as a concurrent reading aid. That means it works while a specialist reads the scan. It identifies suspected saccular aneurysms larger than 3 mm on head CTA. A saccular aneurysm is a small, berry-shaped bulge in a brain artery. The tool reports where the finding sits and how big it is.
The second version targets follow-up. For people with a known aneurysm, it gives quantitative measurements and compares exams to show change over time. Diagnostic Imaging says the follow-up feature will be shown at the RSNA meeting. Bracco’s research head, Fabio Tedoldi, framed the need this way: “For a patient with an unruptured aneurysm, the follow-up scan always brings the same question: Has it changed?”
Small findings can be easy to miss when a worklist keeps growing. A reading aid is built for that moment. It does not replace the radiologist.
Limits to Keep in Mind
The companies say the software is used alongside review of the CTA images. They also say it should not replace a full patient evaluation or a physician’s review. It should not be the sole basis for a diagnosis.
Several things remain unpublished in the sources we opened:
- Sensitivity, specificity or false-alarm rates.
- Details of any clinical study behind the clearance.
- Price or which hospitals will buy it.
- A U.S. launch date. The companies say they are preparing for commercial introduction and will show the tool at RSNA 2026 in Chicago, November 29 to December 3.
The tool also covers only aneurysms above 3 mm on CTA. All commentary we found came from the companies. We did not find independent expert review. Software of this kind can also flag findings that turn out to be normal, which means extra follow-up for some people.
Why It Matters to You
This is cleared in the United States, but not yet in wide use. If you have a head CT angiogram, the software may someday help your radiologist, but you cannot choose it. People with a known aneurysm could see more consistent measurements between scans, though that is a stated goal, not a proven result. If you have questions about your own scan, ask your care team how images are reviewed and what a follow-up schedule should look like. This is general information, not medical advice.
We have covered similar regulator steps for consumer devices, such as Meta’s FDA-cleared hearing aid feature, and clinician-facing AI, such as the OpenEvidence and Anthropic plan. Clinical imaging tools like this one sit in a different category: they are used by specialists, not bought by patients.
Sources
- PR Newswire, Bracco and Avicenna.AI release, November 13, 2026.
- AuntMinnie, “Bracco, Avicenna.AI get FDA clearance for brain aneurysm AI software,” November 13, 2026.
- Diagnostic Imaging, Jeff Hall, “FDA Clears CTA-Based AI Software for Brain Aneurysm Detection and Follow-Up,” November 13, 2026.
- FDA 510(k) database entry for K262062, CINA-Aneurysm, decision date October 20, 2026 (page last updated October 26, 2026).