FDA Clears CTA-Based AI Software for Brain Aneurysm Detection and Follow-Up

The Food and Drug Administration (FDA) has issued 510(k) clearance for Uptunity | Aneurysm, an adjunctive AI-enabled software that may improve detection and assessment of brain aneurysms on head computed tomography angiography (CTA) images.

Developed by Bracco and Avicenna.AI, the computer-assisted detection (CADe) and diagnosis (CADx) software identifies suspected saccular brain aneurysms greater than 3 mm on head CTA and provides radiologists with insights on the location and size of the aneurysms.

Bracco said the follow-up functionality (MIMPS) for Uptunity | Aneurysm, which will be showcased at the upcoming RSNA conference, offers quantitative measurements and comparison between examinations to assess changes in known aneurysms over time.

"For a patient with an unruptured aneurysm, the follow-up scan always brings the same question: Has it changed?" said Fabio Tedoldi, PhD, the head of global research and development at Bracco Imaging. "Uptunity | Aneurysm supports physicians from first detection through subsequent monitoring with comparable readings at every exam. Precision, to us, means not only finding, but following up."

The two adjunctive AI products covered under the FDA clearance for Uptunity | Aneurysm FDA are Uptunity | Aneurysm Detection and Uptunity | Aneurysm Management, according to Bracco.