Bracco and Avicenna.AI win FDA clearance for AI that flags brain aneurysms on CT scans

Bracco and Avicenna.AI have received US FDA 510(k) clearance for UPTUNITY Aneurysm, AI software that helps radiologists detect and assess brain aneurysms on CT angiography scans of the cerebral arteries, the companies announced. It is the first product in UPTUNITY, Bracco's new portfolio of AI tools for image interpretation, and was developed with Avicenna.AI.

The software works inside the radiologist's existing reading environment as a concurrent reading aid for trained specialists, covering both detection and follow-up of known aneurysms, including changes in growth. The companies cite an estimate that one in 50 US adults has an unruptured brain aneurysm, often without symptoms, and that small aneurysms can be missed on scans done for other reasons. "The clinical decision stays where it belongs: with the radiologist," said Cosimo DePinto of Bracco Americas. Bracco will show the software at the RSNA meeting in Chicago from 29 November.