Bracco and Avicenna.AI Announce FDA Clearance for UPTUNITY™ | Aneurysm, a New AI-Enabled Software for Brain Aneurysm Detection and Assessment
Developed in collaboration with Avicenna.AI, the newly FDA-cleared technology introduces UPTUNITY™, Bracco's new portfolio of AI-enabled clinical decision support solutions.
MILAN, Nov. 13, 2026 /PRNewswire/ -- Bracco and Avicenna.AI today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of UPTUNITY™ | Aneurysm, the first offering within the new UPTUNITY™ portfolio and a result of Bracco's collaboration with Avicenna.AI. Designed to support medical specialists in detecting and assessing brain aneurysms on cerebral arteries computed tomography angiography (CTA) images, UPTUNITY | Aneurysm integrates AI assistance into the radiologist's reading workflow.
UPTUNITY reinforces Bracco's Digital Health strategy by expanding the company's capabilities into interpretive AI. The portfolio provides clinical decision support capabilities for specific needs in image interpretation. It complements Bracco's existing AI offerings, including AiMIFY®, developed with Subtle Medical, which applies AI to amplify existing contrast enhancement in brain MRI for improved lesion visualization.1 With UPTUNITY, Bracco 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, Marketing & Commercial Operations, 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."
An estimated one in 50 U.S. adults has an unruptured brain aneurysm, a condition that is often asymptomatic.2 Aneurysms can be difficult to detect on cerebral arteries CTA and may be discovered incidentally during imaging performed to evaluate other clinical concerns.3,4 For known aneurysms, consistent follow-up and assessment of changes in growth are important to ongoing clinical evaluation.4
UPTUNITY | Aneurysm spans 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 3 mm on head CTA images and provides information about their presence, location and size for assessment and characterization. For known aneurysms, the follow-up functionality (MIMPS) provides quantitative measurements and comparison between examinations to assess changes over time. The integrated workflow extends from initial identification through longitudinal follow-up.
The software provides information for use alongside review of the CTA images, while maintaining physician control over clinical decision-making. 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.5,6
"For a patient with an unruptured aneurysm, the follow-up scan always brings the same question: has it changed?" said Fabio Tedoldi, PhD, Head of Global Research & Development, 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 and Avicenna.AI announced their strategic partnership in March 2026 to advance AI applications in contrast-enhanced computed tomography. The companies are now preparing for the commercial introduction of UPTUNITY | Aneurysm in the United States. Avicenna.AI will lead promotion and commercial distribution of the solution.
"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 millimeter by millimeter 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 >3 mm and track how it changes over time," said Cyril Di Grandi, CEO and co-founder, 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 Radiological Society of North America (RSNA) 2026 Annual Meeting, taking place November 29–December 3 in Chicago. To learn more about Bracco's presence at RSNA 2026, including UPTUNITY | Aneurysm and the company's vision for artificial intelligence, visit www.bracco.com/RSNA.
UPTUNITY | Aneurysm has received 510(k) clearance from the U.S. Food and Drug Administration under K262062 and K262147. UPTUNITY™ | Aneurysm Detection and UPTUNITY™ | Aneurysm Management are the commercial names for CINA-Aneurysm (K262062) and CINA-Aneurysm+ (K262147), respectively. For complete operating instructions, warnings, precautions and other important safety information, refer to the instructions for use.
About Bracco
Bracco Group, founded in 1927, is a global leader in diagnostic imaging committed to advancing healthcare and improving people's lives by shaping the future of prevention and precision medicine. The company operates in the healthcare sector in more than 100 countries, with a workforce of over 4,000 employees and consolidated annual revenues of approximately €2 billion, with a global footprint.
With a strong commitment to innovation, investing around 9% of its reference turnover in research and development, Bracco develops and provides a broad portfolio of pharmaceutical products for diagnostic imaging, including contrast agents for X-ray, computed tomography and magnetic resonance imaging, as well as microbubbles for contrast-enhanced ultrasound and molecular imaging agents such as radioactive tracers and novel positron emission tomography imaging agents, alongside artificial intelligence-based solutions. It is also a global market leader in advanced contrast management technologies for cardiovascular angiography and radiology imaging. Discover more at www.bracco.com.
About Avicenna.AI
Founded in 2018, Avicenna.AI specializes in the development of artificial intelligence solutions dedicated to emergency and incidental medical imaging, using deep learning techniques to identify, detect and quantify critical pathologies from CT images. Co-founded by Cyril Di Grandi, co-founder of Olea Medical, and Dr. Peter Chang, American radiologist and AI expert, Avicenna.AI's mission is to support radiologists' diagnosis, ensure faster and more reliable detection of serious pathologies, and improve the quality of patient care through its AI tools for radiology. For more information, follow us on LinkedIn and visit our website: www.avicenna.ai
Media Contacts:
Bracco Press Contact
Alessandra Vulpiani
Bracco Imaging, Senior Marketing Communication Manager
Alessandra.Vulpiani@bracco.com
Avicenna.AI Press Contact
Stéphanie Bellavia
Avicenna.AI, Marketing Manager
stephanie.bellavia@avicenna.ai
1Venkata SP, Arnold TC, Serra SC, et al. Deep-Learning Based Contrast Boosting: A Multi-Center Multi-Reader Study on Clinical Performance With Standard Contrast Enhanced Brain MRI. J Magn Reson Imaging. 2026:1-15. doi:10.1002/jmri.70460.
2Brain Aneurysm Foundation. Brain Aneurysm Statistics and Facts. Available at: https://www.bafound.org/statistics-and-facts/. Accessed October 28, 2026.
3Biddle G, Assadsangabi R, Broadhead K, Hacein-Bey L, Ivanovic V. Diagnostic Errors in Cerebrovascular Pathology: Retrospective Analysis of a Neuroradiology Database at a Large Tertiary Academic Medical Center. AJNR Am J Neuroradiol. 2022;43(9):1271-1278. doi:10.3174/ajnr.A7596
4Thompson BG, Brown RD Jr, Amin-Hanjani S, et al. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015;46(8):2368-2400.
5U.S. Food and Drug Administration. 510(k) Summary K262062, CINA-Aneurysm.
6U.S. Food and Drug Administration. 510(k) Summary K262147, CINA-Aneurysm+.
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