The clearance
Bracco and Avicenna.AI said the U.S. Food and Drug Administration has granted 510(k) clearance to UPTUNITY | Aneurysm, the first offering in Bracco's new UPTUNITY portfolio of AI-enabled clinical decision support software. The clearance covers two devices: CINA-Aneurysm, cleared under K262062 and sold as UPTUNITY | Aneurysm Detection, and CINA-Aneurysm+, cleared under K262147 and sold as UPTUNITY | Aneurysm Management.
What the software is built to do
According to the companies, the software is intended for use as a concurrent reading aid by appropriately trained medical specialists and runs inside the reading environment radiologists already use. It identifies suspected saccular brain aneurysms larger than 3 mm on cerebral artery CT angiography images and provides information about their presence, location and size. A follow-up function supplies quantitative measurements and comparisons between examinations to assess change over time.
One in 50 adults
An estimated one in 50 U.S. adults has an unruptured brain aneurysm, a condition that is often asymptomatic, the companies said. Aneurysms can be difficult to detect on cerebral artery CTA and may be discovered incidentally during imaging carried out to evaluate other clinical concerns, the release stated.
Limits and rollout
Bracco and Avicenna.AI said the software provides information for use alongside review of the CTA images and keeps clinical decision-making with the physician. It is not intended to replace a full patient evaluation or a qualified physician's review and should not be solely relied upon to make or confirm a diagnosis, they said. The companies said they are preparing commercial introduction in the United States, with Avicenna.AI leading promotion and distribution, and that the product will be shown at the Radiological Society of North America 2026 annual meeting, held November 29 to December 3 in Chicago.
