#Brazil #São Paulo #Bracco Imaging #Subtle Medical #AiMIFY

Bracco Imaging Achieves ANVISA Approval for AiMIFY™ in Brazil

In a significant advancement for diagnostic imaging, Bracco Imaging S.p.A., a global leader in the field, has confirmed that its innovative software, AiMIFY™, has been granted approval by Brazil's regulatory body, ANVISA (Agência Nacional de Vigilância Sanitária). This pivotal milestone, announced on November 20, 2025, follows earlier approvals from the U.S. Food and Drug Administration (FDA) and the CE Marking in Europe, marking Bracco's robust progression in expanding access to cutting-edge imaging solutions across Latin America.

The Role of AiMIFY™

AiMIFY™ is an AI-powered software specifically designed to enhance the quality of Magnetic Resonance Imaging (MRI) of the brain. By utilizing advanced artificial intelligence technology, AiMIFY™ significantly improves the contrast enhancement of brain MRI scans post-administration of Gadolinium-Based Contrast Agents (GBCAs), with the ability to boost contrast values up to two times more than initial readings. This technological advancement is crucial as it provides radiologists with clearer visual information, particularly beneficial for identifying small and subtly enhanced lesions.

Impact on Healthcare in Brazil

The ANVISA approval is a monumental step that allows Bracco Imaging to distribute AiMIFY™ to imaging providers across Brazil, a region recognized as an essential market in Latin America's healthcare landscape. By implementing AiMIFY™, these providers are expected to gain enhanced diagnostic capabilities, ultimately leading to improved patient outcomes. According to Sascha Daeuber, the Global Radiology Platform Leader at Bracco Imaging, this approval reflects their commitment to advancing precision diagnostics. He stated, “By enabling radiologists to achieve clearer insights from brain MRI, AiMIFY™ plays a vital role in expanding access to innovative imaging solutions.”

Tommaso Montemurno, General Manager for Latin America at Bracco Imaging, highlighted that MRI remains the preferred imaging modality in the region. He emphasized Bracco's dedication to supporting radiologists by providing innovative tools to elevate diagnostic standards. The ANVISA approval reinforces Bracco's objective of advancing healthcare technologies in Brazil through collaboration with local imaging facilities.

Collaboration with Subtle Medical

This achievement is also a testament to Bracco's partnership with Subtle Medical, an innovator in AI-driven medical imaging software. Josh Gurewitz, Chief Commercial Officer at Subtle Medical, expressed excitement regarding the integration of AiMIFY™ into Brazilian healthcare, emphasizing its role in enhancing global access to advanced imaging solutions. By harnessing the synergy between AiMIFY™ and SubtleHD™, Brazilian imaging providers can achieve improved diagnostic precision and operational efficiency.

Conclusion

The successful ANVISA approval for AiMIFY™ not only signifies a remarkable milestone for Bracco Imaging but also promises to transform the landscape of MRI diagnostics in Brazil and beyond. With a commitment to innovation and excellence, Bracco Imaging is poised to continue its leadership in diagnostic imaging, advocating for enhanced diagnostic standards and patient care across Latin America. As AiMIFY™ prepares to enter the Brazilian market, the future looks bright for diagnostic imaging professionals and the patients they serve.

For more information on Bracco Imaging and their expanding portfolio of diagnostic imaging solutions, visit Bracco Imaging.