Bracco Expands AI Imaging Portfolio

The AiMIFY® software, a collaboration between Bracco and Subtle Medical, received FDA clearance in the U.S. in October 2024 as a Class II medical device for brain MRI. This AI-powered tool can amplify the contrast enhancement of brain MR images up to double the level achieved with a standard dose of gadolinium-based contrast agents (GBCAs), improving lesion visibility. The technology has been validated across various MRI scanners, patient demographics, and pathologies. The partnership with Avicenna.AI extends Bracco's AI focus to contrast-enhanced CT, specifically targeting computer-aided detection and diagnosis for brain CT angiography. Avicenna.AI, founded in 2018, has a portfolio of FDA-cleared and CE-marked AI tools for identifying conditions like stroke, pulmonary embolism, and aortic dissection. FDA submission for the new joint AI applications is anticipated in the latter half of 2026. This expansion into AI-driven workflow and interpretation tools aligns with a broader industry trend of leveraging artificial intelligence to enhance diagnostic accuracy and streamline radiologist workflows. AI applications are increasingly used to automate routine tasks, prioritize urgent cases, and generate preliminary reports, allowing radiologists to focus on more complex interpretations and reducing diagnostic errors. The strategic push into outpatient-focused AI tools comes as imaging services increasingly shift from hospitals to freestanding centers. This migration is driven by payers seeking lower-cost care settings and patients preferring more convenient access. Vizient projects that advanced outpatient imaging volumes will climb by 14% over the next decade. This site-of-care shift creates a significant opportunity for mobile imaging providers and specialized outpatient centers, particularly in states like Florida with high freestanding imaging penetration. However, these centers face financial pressures from declining Medicare and commercial payer reimbursements, including a 2.9% average Medicare payment rate decrease for physicians in 2025. Health systems are responding by expanding their own freestanding imaging footprints through acquisitions, joint ventures, or new construction to remain competitive and mitigate volume loss from hospital-based departments. For equipment manufacturers and service providers, this trend necessitates a focus on scalable, efficient technologies like AI that can optimize throughput and address staffing shortages in these growing outpatient settings.