Bracco, Avicenna.AI get FDA clearance for brain aneurysm AI software

Bracco and Avicenna.AI have received U.S. Food and Drug Administration (FDA) 510(k) clearance for Uptunity Aneurysm, AI software that detects and assesses brain aneurysms on cerebral CT angiography (CTA) images.

The software, intended as a concurrent reading aid, identifies suspected saccular brain aneurysms larger than 3 mm on head CTA and provides information on their presence, location, and size. For known aneurysms, its follow-up functionality provides quantitative measurements and comparisons between exams to assess changes over time.

Uptunity Aneurysm is the first product in Bracco’s new Uptunity portfolio of interpretive AI software, developed through the company’s partnership with Avicenna.AI. Avicenna.AI will lead promotion and commercial distribution in the U.S.

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