Bracco and Avicenna.AI today announced the US Food and Drug Administration (FDA) 510(k) clearance of UPTUNITY-Aneurysm—the first offering within Bracco’s new UPTUNITY portfolio, and a result of the company’s collaboration with Avicenna.AI. Designed to support medical specialists in detecting and assessing brain aneurysms on computed tomography angiography (CTA) images of cerebral arteries, UPTUNITY-Aneurysm integrates artificial intelligence (AI) assistance into a radiologist’s reading workflows, as stated in a press release.
UPTUNITY is said to complement Bracco’s existing AI offerings, including AiMIFY, which was developed with Subtle Medical to apply AI in order to amplify existing contrast enhancement on brain magnetic resonance imaging (MRI) for improved lesion visualisation. Bracco says that, with UPTUNITY, it continues to invest in digital health technologies that extend its support for radiologists across the imaging continuum and advance innovation beyond contrast agents.
“A small incidental aneurysm on a head CTA can easily be overlooked when the worklist keeps growing,” said Cosimo DePinto, executive vice president of marketing and 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.”
UPTUNITY-Aneurysm is designed to span brain aneurysm detection and ongoing follow-up across the radiologist’s workflow. For detection, the computer-assisted detection (CADe) and diagnosis (CADx) software is intended for use as a concurrent reading aid by appropriately trained medical specialists. It identifies suspected saccular brain aneurysms greater than 3mm on head CTA images, and provides information about their presence, location and size for assessment and characterisation. For known aneurysms, the follow-up functionality—a medical image management and processing system (MIMPS)—provides quantitative measurements and comparison between examinations to assess changes over time. The integrated workflow extends from initial identification through longitudinal follow-up, according to Bracco.
The company also states that this software provides information for use alongside review of the CTA images while maintaining physician control over clinical decision-making, and 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.
“For a patient with an unruptured aneurysm, the follow-up scan always brings the same question: has it changed?” commented Fabio Tedoldi, 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.”
Bracco announced its strategic partnership with Avicenna.AI—intended to advance AI applications in contrast-enhanced CT imaging—in March 2026 alongside the commercial launch of its AiMIFY software solution in the EU. Bracco and Avicenna.AI are now preparing for the commercial introduction of UPTUNITY-Aneurysm in the USA, with the latter company set to lead promotion and commercial distribution.
“Contrast agents were created to make the invisible visible. A brain aneurysm is exactly that kind of hidden finding: silent, often discovered by chance, then followed millimetre by millimetre for years. Bracco has spent decades lighting up the vessels, but an image only helps if what it shows is seen. Avicenna.AI brings AI assistance to those images, helping radiologists detect an aneurysm >3mm and track how it changes over time,” stated Cyril Di Grandi, chief executive officer (CEO) and co-founder of Avicenna.AI. “UPTUNITY-Aneurysm combines these two strengths, turning a head CTA into a story the radiologist can follow, from the first finding through every follow-up. Neither of us could have done this alone, and that is the point of this partnership.”
UPTUNITY-Aneurysm will be showcased at the upcoming Radiological Society of North America (RSNA) annual meeting (29 November–3 December, Chicago, USA), Bracco also says.
