Bracco and Avicenna.AI Introduce AI-Enabled UPTUNITY™ for Aneurysm Detection

Bracco and Avicenna.AI have announced the 510(k) clearance of UPTUNITY™ | Aneurysm by the U.S. Food and Drug Administration (FDA). This is the inaugural offering within the new UPTUNITY™ portfolio, aimed at supporting medical specialists in the detection and assessment of brain aneurysms on cerebral arteries computed tomography angiography (CTA) images. The integration of artificial intelligence (AI) into the reading workflow for radiologists is emphasized through this technology.

UPTUNITY is aligned with Bracco's Digital Health strategy, broadening the company's interpretive AI capabilities. It enhances clinical decision support for image interpretation, complementing existing AI solutions like AiMIFY®, which is designed to improve lesion visualization in brain MRI through AI-enhanced contrast enhancement. Bracco aims to extend its support to radiologists beyond conventional contrast agents.

According to Cosimo DePinto, Executive Vice President, Marketing & Commercial Operations, Bracco Americas, "A small incidental aneurysm on a head CTA can easily be overlooked when the worklist keeps growing. UPTUNITY | Aneurysm works inside the reading environment radiologists already know and helps find the aneurysm hiding in the CT scan."

The software utilizes computer-assisted detection (CADe) and diagnosis (CADx) functionalities, identifying suspected saccular brain aneurysms greater than 3 mm. It provides relevant information about their presence, location, and size for further assessment. The follow-up feature (MIMPS) allows for ongoing monitoring and measures changes in size over time, underscoring its role in long-term patient management.

UPTUNITY | Aneurysm is designed for concurrent reading by trained specialists, maintaining physician control over clinical decision-making. It does not replace comprehensive evaluations or qualified physician reviews. The emphasis is on aiding radiologists through detection and follow-ups, ensuring precision in both finding and monitoring aneurysms, as highlighted by Fabio Tedoldi, PhD, Head of Global Research & Development, Bracco Imaging.

Bracco and Avicenna.AI established their strategic partnership in March 2026, focusing on AI applications in contrast-enhanced computed tomography. They are preparing for the commercial rollout of UPTUNITY | Aneurysm in the United States, with Avicenna.AI leading promotional and distribution efforts.

UPTUNITY | Aneurysm will be featured at the Radiological Society of North America (RSNA) 2026 Annual Meeting, scheduled for November 29–December 3 in Chicago. For further information about Bracco's presence at the RSNA and UPTUNITY | Aneurysm, visit www.bracco.com/RSNA.

The FDA clearance for UPTUNITY | Aneurysm is associated with K262062 and K262147. Its commercial names include CINA-Aneurysm (K262062) and CINA-Aneurysm+ (K262147). For operational instructions and safety information, refer to the official instructions for use.