AI Brain Scans Gain Traction: Bracco Imaging Expands Reach in Latin America

NEW YORK, NY – November 20, 2025

Bracco Imaging Secures Brazilian Approval for AI-Powered Scan Enhancement

Bracco Imaging S.p.A. has received approval from the Brazilian Health Regulatory Agency (ANVISA) for AiMIFY™, its innovative AI-powered software designed to enhance brain MRI scans. This regulatory green light expands the availability of AiMIFY™ to Brazil, a significant market in Latin America, following prior clearances in the United States and Europe. The technology, developed in partnership with Subtle Medical, aims to improve the visualization of small and poorly enhanced lesions, potentially leading to earlier and more accurate diagnoses.

AiMIFY™ addresses a critical need in neuroimaging. Current diagnostic capabilities often struggle to clearly identify subtle abnormalities, leading to delayed diagnoses or the need for repeat scans. By amplifying contrast enhancement through sophisticated AI algorithms, the software promises to improve diagnostic confidence and potentially reduce healthcare costs. “The ability to enhance image quality without increasing contrast dose is a significant step forward,” notes a leading radiologist based in São Paulo. “It addresses concerns around contrast-induced nephropathy while also improving the visibility of subtle lesions.”

The Rising Tide of AI in Medical Imaging

The approval of AiMIFY™ in Brazil is part of a broader trend of AI integration into medical imaging. Several companies, including Siemens Healthineers, GE HealthCare, and Philips Healthcare, are actively developing and deploying AI-powered solutions designed to enhance image quality, accelerate scan times, and improve diagnostic accuracy. These technologies are not simply incremental improvements; they represent a fundamental shift in how medical images are acquired and interpreted.

“AI is becoming an indispensable tool for radiologists,” says a healthcare technology analyst. “It's helping them to manage increasing workloads, reduce errors, and provide better patient care.” The market for AI in medical imaging is projected to reach nearly $450 million globally by 2030, with Brazil poised to become a key growth driver. The country's rapidly expanding healthcare system and growing demand for advanced diagnostic capabilities are fueling the adoption of these innovative technologies.

Bracco’s Strategic Push into Latin America

For Bracco Imaging, the ANVISA approval represents a strategic expansion into a key emerging market. Latin America is a region with significant growth potential, driven by increasing healthcare spending and a growing middle class. By securing regulatory approval in Brazil, Bracco gains a competitive advantage and positions itself to capitalize on this growth.

The company’s partnership with Subtle Medical has been crucial to its success. Subtle Medical’s expertise in AI-powered medical imaging has allowed Bracco to quickly develop and deploy innovative solutions like AiMIFY™. “This collaboration has been instrumental in accelerating our innovation pipeline,” a Bracco spokesperson stated. “It allows us to combine our expertise in contrast agents and imaging solutions with Subtle Medical’s cutting-edge AI technology.”

Brazil's commitment to fostering innovation in healthcare is also playing a role. The country recently joined the HealthAI Global Regulatory Network, signaling its commitment to a transparent and supportive regulatory environment for AI in healthcare. This membership will help to streamline the approval process for innovative technologies and encourage investment in the sector. A leading Brazilian healthcare administrator noted, “The government is actively working to create a regulatory framework that encourages innovation while ensuring patient safety.”

Beyond Brazil, Bracco is actively exploring opportunities to expand its presence in other Latin American markets. The company is currently seeking regulatory approval for AiMIFY™ in several other countries in the region, and is also investing in local partnerships to expand its distribution network. The company's long-term strategy is to become a leading provider of diagnostic imaging solutions in Latin America, and AiMIFY™ is a key component of that strategy.

The competition in the AI-enhanced imaging space is fierce. Siemens Healthineers' Deep Resolve technology and GE HealthCare’s AI-powered reconstruction capabilities are examples of competing solutions. However, AiMIFY’s focus on enhancing contrast in brain MRIs presents a specific niche, and its performance in trials has been impressive. “The real differentiator will be clinical validation and demonstrating improved patient outcomes,” a radiologist specializing in neuroimaging added. “That’s what will ultimately drive adoption.”