Bracco and Avicenna.AI Announce FDA Clearance for UPTUNITY™ | Aneurysm
The FDA clearance represents a further milestone in the strategic collaboration between Bracco and Avicenna.AI and in Bracco’s continued development of its Digital Health portfolio.
MILAN, NOVEMBER 13, 2026 – Bracco and Avicenna.AI today announced U.S. Food and Drug Administration (FDA) 510(k) clearance, under K262062 and K262147, 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 encompasses clinical decision support technologies for specific needs in image interpretation. 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.
An estimated one in 50 U.S. adults has an unruptured brain aneurysm, a condition that is often asymptomatic.1 Aneurysms can be difficult to detect on cerebral arteries CTA and may be discovered incidentally during imaging performed to evaluate other clinical concerns.2,3 For known aneurysms, consistent follow-up and assessment of changes in growth are important to ongoing clinical evaluation.3
Bracco and Avicenna.AI announced their strategic partnership in March 2026 to advance AI applications in contrast-enhanced computed tomography.
“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. and Avicenna.AI brings AI assistance to those images.
Neither of us could have done this alone, and that is the point of this partnership” said Cyril Di Grandi, CEO and co-founder, Avicenna.AI.
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.
REGULATORY STATUS
This announcement relates to the product’s regulatory clearance in the United States
UPTUNITY | Aneurysm has received 510(k) clearance from the U.S. Food and Drug Administration under K262062 and K262147. For complete operating instructions, warnings, precautions and other important safety information, refer to the instructions for use.
UPTUNITY™ | Aneurysm is not CE marked and is not available for sale in the European Union. Product availability and regulatory status vary by country.
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+.