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