Bracco's UPTUNITY Brain Aneurysm Software Cleared by FDA: Flags Aneurysms Over 3 mm on Head CTA and Tracks Changes Over Time
Bracco and Avicenna.AI announced on November 13 that their jointly developed software, UPTUNITY | Aneurysm, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). It is the first offering in Bracco's new UPTUNITY portfolio of clinical decision support solutions, designed to support medical specialists in detecting and assessing brain aneurysms on cerebral arteries computed tomography angiography (CTA) images.
According to the companies, the software integrates into the radiologist's existing reading workflow as a concurrent reading aid. It identifies suspected saccular brain aneurysms greater than 3 mm on head CTA images and provides information about their presence, location and size for assessment and characterization. For known aneurysms, its follow-up functionality provides quantitative measurements and comparison between examinations to assess changes over time.
The companies said an estimated one in 50 U.S. adults has an unruptured brain aneurysm, a condition that is often asymptomatic. Aneurysms can be difficult to detect on cerebral arteries CTA and may be discovered incidentally during imaging performed for other concerns. The software provides information for use alongside review of the CTA images, while physician control over clinical decision-making is maintained; 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.
"A small incidental aneurysm on a head CTA can easily be overlooked when the worklist keeps growing," said Cosimo DePinto, Executive Vice President, Marketing & Commercial Operations at Bracco Americas. "UPTUNITY | Aneurysm works inside the reading environment radiologists already know and helps find the aneurysm hiding in the CT scan. The clinical decision stays where it belongs: with the radiologist."
The clearance covers two 510(k) numbers, K262062 and K262147, whose commercial names are UPTUNITY | Aneurysm Detection and UPTUNITY | Aneurysm Management, built on Avicenna.AI's CINA-Aneurysm and CINA-Aneurysm+. The two companies announced their strategic partnership in March 2026 to advance super intelligence (SI) applications in contrast-enhanced computed tomography. They are now preparing the commercial introduction of the software in the United States, with Avicenna.AI leading promotion and commercial distribution. The software will be showcased at the Radiological Society of North America (RSNA) 2026 Annual Meeting, taking place November 29 to December 3 in Chicago.
(Source: Bracco and Avicenna.AI)
Source: Bracco and Avicenna.AI
Published by GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监管局（FDA）总部大楼（固定图库）。FDA 官方图。 / The U.S. Food and Drug Administration headquarters (file photo). Photo: U.S. Food and Drug Administration.
