AI-Enabled Software for Brain Aneurysm Detection, Assessment Gets FDA Approval

Nov. 13, 2026  -- Bracco and Avicenna.AI have 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 expands 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."

Aneurysm

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.

CTA Image Review

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 in Chicago. To learn more 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. 

References

1. Venkata 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.

2. Brain Aneurysm Foundation. Brain Aneurysm Statistics and Facts. Available at: https://www.bafound.org/statistics-and-facts/. Accessed October 28, 2026.

3. Biddle 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

4. Thompson 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.

5. U.S. Food and Drug Administration. 510(k) Summary K262062, CINA-Aneurysm.

6. U.S. Food and Drug Administration. 510(k) Summary K262147, CINA-Aneurysm+.