# Bracco and Avicenna.AI receive FDA clearance for UPTUNITY aneurysm AI

> The AI software, cleared by the FDA on Nov 13 2026, assists radiologists in detecting and tracking brain aneurysms larger than 3 mm on CTA scans.

Oossa · 2026-11-13 · https://oossa.com/en/bracco-and-avicenna-ai-receive-fda-clearance-for-uptunity-aneurysm-ai

Bracco and Avicenna.AI announced that the U.S. Food and Drug Administration granted 510(k) clearance for UPTUNITY™ | Aneurysm on Nov 13 2026. The AI tool integrates into the radiologist’s workflow and flags suspected saccular aneurysms over 3 mm on head CT angiography, also measuring size for follow‑up scans. Bracco plans to launch the product in the United States, with Avicenna.AI handling promotion and distribution.

The clearance covers two versions: CINA‑Aneurysm (K262062) for detection and CINA‑Aneurysm+ (K262147) for longitudinal management. The companies will showcase the solution at the RSNA 2026 meeting in Chicago.

## The facts

- FDA 510(k) clearance numbers K262062 and K262147
- Detects aneurysms >3 mm on cerebral CTA and provides size tracking

## Why it matters

Radiologists can more reliably spot small, often missed brain aneurysms and monitor their growth, potentially improving patient outcomes.

## 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-302938500.html) – PR Newswire RSS, 2026-11-13

Last updated: 2026-11-13