Bracco Imaging and Avicenna.AI have received US Food and Drug Administration (FDA) clearance on a jointly developed tool for detecting and assessing brain aneurysms based on computed tomography angiography (CTA) images, representing the first regulatory clearance for the pair since entering a strategic partnership in March 2026.
UPTUNITY | Aneurysm is designed to analyse CTA images of the cerebral arteries to identify suspected saccular brain aneurysms greater than 3mm in size, providing information regarding their location and size for radiologists’ subsequent assessment and characterisation. For known aneurysms, meanwhile, the artificial intelligence (AI)-based tool includes a follow-up functionality for quantitative measurement and comparison between examinations to assess changes over time.
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The aneurysm detection tool represents the first product within Bracco’s UPTUNITY portfolio, which the Italian company says reinforces its digital health strategy and expands its capabilities into what it dubs ‘interpretive AI’.
UPTUNITY | Aneurysm complements Bracco’s existing AI offerings, including AiMIFY, a tool for enhancing contrast in brain magnetic resonance imaging (MRI) scans that it developed alongside Subtle Medical, the company added.
“For a patient with an unruptured aneurysm, the follow-up scan always brings the same question: has it changed? UPTUNITY | Aneurysm supports physicians from first detection through subsequent monitoring, with comparable readings at every exam,” commented Fabio Tedoldi, Bracco’s head of global research and development.
UPTUNITY | Aneurysm is being showcased at the Radiological Society of North America (RSNA) 2026 Annual Meeting, taking place from 29 November to 3 December in Chicago. Meanwhile, the companies are now preparing for the tool’s US commercialisation, with Avicenna.AI primed to take the lead on promotion and distribution activities.
Avicenna.AI’s CEO, Cyril Di Grandi, commented: “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 greater than 3mm and track how it changes over time.
“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.”
AI continues to have a profound impact on the medical imaging space, a fact amply demonstrated by the FDA’s list of AI-based medical devices approved in 2026 – with the vast majority of approved devices indicated for radiology-based functions. According to GlobalData analysis, the AI market across healthcare is growing at a compound annual growth rate (CAGR) of around 37% and is expected to reach a $57.4bn valuation in 2029.
