Bracco and Avicenna.AI announced on November 13, 2026, that they received U.S. Food and Drug Administration 510(k) clearance for UPTUNITY | Aneurysm. The software is designed to assist medical specialists in detecting and assessing brain aneurysms on cerebral arteries computed tomography angiography images.
What the Software Does
UPTUNITY | Aneurysm integrates AI assistance into the radiologist reading workflow to identify suspected saccular brain aneurysms greater than 3 mm on head CTA images.
For known aneurysms, the follow-up functionality provides quantitative measurements and comparison between examinations to assess changes over time.
Partnership and Commercial Plans
The companies announced their strategic partnership in March 2026 to advance AI applications in contrast-enhanced computed tomography.
Avicenna.AI will lead promotion and commercial distribution of the solution in the United States, and the software will be showcased at the Radiological Society of North America 2026 Annual Meeting.
Key facts and where they come from
- Bracco and Avicenna.AI received FDA 510(k) clearance for UPTUNITY | Aneurysm.
Bracco and Avicenna.AI today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of UPTUNITY™ | Aneurysm
- The software identifies suspected saccular brain aneurysms greater than 3 mm on head CTA images.
It identifies suspected saccular brain aneurysms greater than 3 mm on head CTA images and provides information about their presence, location and size
- Avicenna.AI will lead promotion and commercial distribution of the solution in the United States.
Avicenna.AI will lead promotion and commercial distribution of the solution.
The catch
- The announcement does not disclose the commercial pricing or specific release date for UPTUNITY | Aneurysm.
- The companies note that the software is not intended to replace a full patient evaluation or a qualified physician's review.
