# FDA clears Bracco’s UPTUNITY Aneurysm AI tool for brain scans

> Bracco and Avicenna.AI received 510(k) clearance for UPTUNITY | Aneurysm, software that flags brain aneurysms over 3 mm on CT angiograms.

Oossa · 2026-11-13 · https://oossa.com/en/fda-clears-bracco-s-uptunity-aneurysm-ai-tool-for-brain-scans

Bracco and Avicenna.AI announced that the U.S. Food and Drug Administration has granted 510(k) clearance to UPTUNITY | Aneurysm. The AI‑enabled software works inside a radiologist’s existing CT angiography (CTA) reading workflow and highlights suspected saccular aneurysms larger than 3 mm. It also provides size measurements and tracks changes over time for patients who already have an aneurysm. The clearance covers two commercial versions – UPTUNITY | Aneurysm Detection (CINA‑Aneurysm, K262062) and UPTUNITY | Aneurysm Management (CINA‑Aneurysm+, K262147). Bracco plans to launch the product in the United States later this year, with Avicenna.AI handling promotion and distribution.

## How the tool fits into radiology practice

Radiologists often read dozens of head CTA studies a day, and small incidental aneurysms can be missed as the worklist grows. UPTUNITY runs as a concurrent reading aid, showing the location, size and confidence score for each detection while leaving the final decision to the physician. For follow‑up exams, the software’s MIMPS module automatically compares current measurements with prior studies, giving a quantitative view of growth or stability. Bracco says the solution extends its digital‑health portfolio, which already includes AiMIFY® for MRI contrast enhancement.

## Why this matters now

An estimated one in 50 U.S. adults carries an unruptured brain aneurysm, most of them silent until discovered incidentally on imaging done for another reason. Early detection and consistent monitoring are key to preventing rupture, which can lead to stroke or death. By flagging aneurysms that are larger than 3 mm, UPTUNITY gives physicians a second set of eyes and a reliable way to measure change over years, potentially reducing diagnostic errors and improving patient follow‑up.

## The facts

- The FDA granted 510(k) clearance under K262062 and K262147 on November 13, 2026.
- UPTUNITY | Aneurysm detects saccular brain aneurysms greater than 3 mm on head CTA images.
- The software provides both detection (CINA‑Aneurysm) and longitudinal management (CINA‑Aneurysm+).
- Bracco and Avicenna.AI announced their partnership in March 2026 to develop AI for contrast‑enhanced CT.
- U.S. estimates say one in 50 adults has an unruptured brain aneurysm.

## Why it matters

For patients with small, hidden aneurysms, the tool could mean earlier warning and more reliable tracking, giving doctors clearer data to decide if treatment is needed. Radiologists gain a safety net that may catch lesions missed during a busy reading session. However, independent studies on diagnostic accuracy are not yet published, so the real‑world impact remains to be seen.

## Sources & references

1. [Bracco and Avicenna.AI Announce FDA Clearance for UPTUNITY™ | Aneurysm, a New AI-Enabled Software for Brain Aneurysm Detection and Assessment](https://www.prnewswire.com/news-releases/bracco-and-avicennaai-announce-fda-clearance-for-uptunity--aneurysm-a-new-ai-enabled-software-for-brain-aneurysm-detection-and-assessment-302938510.html) – PR Newswire RSS, 2026-11-13

Last updated: 2026-11-13