Milan, Italy, November 13, 2026
Bracco Group and Avicenna.AI have announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for UPTUNITY™ | Aneurysm, an artificial intelligence-enabled medical software solution designed to support the detection and assessment of brain aneurysms. Developed through a strategic collaboration between the two companies, the software is the first offering in Bracco’s new UPTUNITY portfolio of AI-enabled clinical decision support solutions. It is designed to assist radiologists and other appropriately trained medical specialists in identifying suspected brain aneurysms on cerebral computed tomography angiography (CTA) images and monitoring known aneurysms over time. The clearance marks an expansion of Bracco’s digital health strategy into AI-assisted image interpretation and strengthens its collaboration with Avicenna.AI in medical imaging technology. The companies are preparing for the commercial introduction of the software in the United States, with Avicenna.AI expected to lead its promotion and commercial distribution.
FDA-Cleared AI Software Supports Brain Aneurysm Detection
UPTUNITY | Aneurysm is designed to identify suspected saccular brain aneurysms greater than 3 mm on head CTA images. The software uses computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) capabilities to provide information about the presence, location and size of suspected aneurysms. These findings are intended to support the radiologist’s assessment and characterization of abnormalities during image interpretation. Brain aneurysms are abnormal bulges in the walls of blood vessels supplying the brain. Many remain unruptured and may not produce noticeable symptoms, meaning they can sometimes be discovered incidentally during imaging performed for other medical reasons. However, an aneurysm that ruptures can cause a life-threatening subarachnoid hemorrhage. According to the Brain Aneurysm Foundation, approximately one in 50 people in the United States has an unruptured brain aneurysm. Detecting these abnormalities and assessing their characteristics are important aspects of clinical evaluation. UPTUNITY | Aneurysm is intended to function as a concurrent reading aid within the radiologist’s existing workflow. It provides additional information alongside the original CTA images rather than replacing the specialist’s interpretation. By highlighting suspected findings, the technology aims to support image review and help clinicians identify abnormalities that may otherwise be difficult to recognize.
Follow-Up Technology Tracks Changes in Known Aneurysms
In addition to initial detection, the software includes a follow-up functionality called MIMPS, which provides quantitative measurements and comparisons between imaging examinations. This capability is designed to help specialists evaluate changes in the size and characteristics of previously identified aneurysms over time. Monitoring is particularly important for patients with unruptured aneurysms who undergo periodic imaging instead of immediate intervention. Comparing measurements from different examinations can help physicians assess whether an aneurysm has changed and determine whether additional clinical evaluation may be necessary. The integrated workflow therefore covers two important stages of aneurysm management: initial identification and longitudinal monitoring. Bracco explained that the software is intended to provide comparable readings across follow-up examinations, supporting consistent assessment during ongoing patient management. The technology is designed to integrate AI assistance into the radiologist’s existing image-reading environment. Importantly, the software does not independently determine treatment decisions. Its output must be considered together with the CTA images, the patient’s clinical history and other relevant medical information. The companies emphasize that it is not intended to replace a complete patient evaluation or the judgment of a qualified physician, and should not be used as the sole basis for making or confirming a diagnosis.
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Bracco and Avicenna.AI Expand AI Imaging Partnership
The FDA clearance builds on the strategic partnership announced by Bracco and Avicenna.AI in March 2026 to advance artificial intelligence applications in contrast-enhanced computed tomography. For Bracco, the UPTUNITY portfolio represents an expansion beyond its established diagnostic imaging and contrast-agent business into AI-supported image interpretation. The company already offers AI-related imaging technologies, including AiMIFY®, developed in collaboration with Subtle Medical, which uses AI to enhance contrast in brain MRI images. The addition of UPTUNITY | Aneurysm strengthens its digital health portfolio and reflects the growing role of AI in supporting radiology workflows. Avicenna.AI specializes in deep-learning solutions for emergency and incidental medical imaging, developing software designed to identify and quantify important abnormalities in CT images. UPTUNITY | Aneurysm has received FDA 510(k) clearance under K262062 and K262147, covering the commercial products UPTUNITY | Aneurysm Detection and UPTUNITY | Aneurysm Management, respectively. The companies plan to showcase the technology at the Radiological Society of North America (RSNA) 2026 Annual Meeting, scheduled for November 29 to December 3 in Chicago. The upcoming commercial introduction in the United States will be an important next step in bringing the AI-enabled solution into clinical imaging environments. The development highlights how collaboration between diagnostic imaging companies and AI specialists is expanding the use of software-based clinical decision support in radiology.
Source: Bracco Group press release
