The Pulse

FDA clears Bracco and Avicenna.AI aneurysm imaging software

UPTUNITY | Aneurysm is designed to help specialists detect suspected brain aneurysms and assess changes on follow-up scans. Bracco and Avicenna.AI are preparing to introduce it commercially in the United States.

AI.info Team · · fact-checked · against 2 sources ↓ · Published 13 Nov 2026

The FDA has cleared AI-enabled software from Bracco and Avicenna.AI designed to help specialists detect and assess brain aneurysms on head scans. The companies said in a Nov. 13 release that they are preparing to introduce UPTUNITY | Aneurysm commercially in the United States.

The software works with computed tomography angiography, or CTA, images of cerebral arteries. It is designed to fit into the radiologist’s reading workflow, providing information for both initial detection and follow-up assessment.

Detection and follow-up

The detection component identifies suspected saccular brain aneurysms greater than 3 mm on head CTA images and supplies information about their presence, location and size. It is intended as a concurrent reading aid for appropriately trained medical specialists.

For known aneurysms, a follow-up function provides quantitative measurements and comparisons between examinations to assess changes over time. The information is used alongside the clinician’s review of the CTA images.

The software is not intended to replace a full patient evaluation or review by a qualified physician, and it should not be the sole basis for making or confirming a diagnosis. Cosimo DePinto, executive vice president of marketing and commercial operations at Bracco Americas, said: “The clinical decision stays where it belongs: with the radiologist.”

Clinical setting

An estimated one in 50 U.S. adults has an unruptured brain aneurysm, a condition that is often asymptomatic, the release says. Aneurysms can be difficult to detect on cerebral arteries CTA and may be found incidentally when imaging is performed for other clinical concerns, the release says.

For aneurysms already known to physicians, the release says consistent follow-up and assessment of growth are important to ongoing clinical evaluation. The software’s follow-up function is intended to support that assessment by comparing measurements across examinations.

Clearance and commercial plans

The detection and management components received FDA 510(k) clearances under K262062 and K262147, respectively. Their commercial names are UPTUNITY | Aneurysm Detection and UPTUNITY | Aneurysm Management; the corresponding cleared device names are CINA-Aneurysm and CINA-Aneurysm+.

Bracco and Avicenna.AI announced their strategic partnership on March 2, 2026, focusing on computer-aided detection and diagnosis in brain CTA. At that time, the partners said the solution was progressing through development and clinical validation at selected sites in the United States and Europe.

Avicenna.AI will lead promotion and commercial distribution of the aneurysm software. The companies plan to showcase it at the Radiological Society of North America’s 2026 annual meeting in Chicago, which runs from Nov. 29 to Dec. 3.

Bracco’s AI portfolio

The aneurysm product is the first offering in Bracco’s UPTUNITY portfolio of AI-enabled clinical decision-support tools. Bracco also offers AiMIFY, developed with Subtle Medical, which applies AI to amplify existing contrast enhancement in brain MRI for lesion visualization.