Bracco Imaging and Subtle Medical Launch Innovative AiMIFY Software for MRI Enhancement in Europe

Introduction

Bracco Imaging S.p.A., a renowned leader in diagnostic imaging, has solidified its position in the European market with the recent announcement regarding its collaboration with Subtle Medical, Inc. They have jointly developed AiMIFY™, an innovative software solution designed to enhance Magnetic Resonance Imaging (MRI) of the brain. Recently, AiMIFY™ received the prestigious CE Mark under the European Medical Device Regulation (MDR), validating its adherence to the EU's health, safety, and environmental standards.

What is AiMIFY™?

AiMIFY™ leverages one of the most advanced technologies in artificial intelligence (AI) to enhance the quality of brain MRI scans, achieving up to twice the contrast enhancement typically attainable with conventional gadolinium-based contrast agents (GBCAs). This significant improvement enables radiologists to see clearer images, especially when examining small and poorly enhanced lesions, thus playing a crucial role in early detection and diagnosis of various medical conditions.

Notably, AiMIFY™ has showcased its unwavering efficacy across numerous validation datasets, which include a wide array of patient demographics, medical pathologies, lesion sizes, different MRI scanners, sequences, and acquisition positions. This broad scope ensures that AiMIFY™ can be utilized effectively in diverse clinical settings.

Statements from the Leaders

Sascha Daeuber, Radiology Platform Leader at Bracco Imaging, expressed enthusiasm about their extended partnership with Subtle Medical. He stated, “From the beginning, Subtle has proven to be an agile and visionary partner.” Daeuber emphasized that the CE Marking for AiMIFY™ signifies a critical milestone and reinforces their vision towards offering innovative AI-enhanced solutions that amplify diagnostic precision, ultimately supporting both radiologists and patients globally.

Meanwhile, Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical, echoed this sentiment. He remarked, “AiMIFY™ represents a new frontier in AI-powered imaging, bringing enhanced clarity and confidence to brain MRI reads.” Shankaranarayanan further added that the software does not require any alterations to current imaging practices, which means seamless integration into existing workflows for healthcare professionals.

The Path Ahead

With the achievement of CE Mark certification, Bracco Imaging and Subtle Medical plan to start commercial preparations for AiMIFY™ in key European markets. Throughout 2025, these efforts will be focused toward ensuring a phased rollout expected between the end of 2025 and early 2026. This gradual introduction will ensure that healthcare providers can adapt to this innovative technology effectively.

In a further highlight, tomorrow AiMIFY™ will feature prominently in a webinar hosted by Applied Radiology, where experts from both companies will share insights on the impactful technology and its implications for the future of MRI diagnostics. The session will be recorded and made available for on-demand viewing.

Conclusion

AiMIFY™ is a game changer in the realm of radiology, combining the prowess of AI with the precision of advanced diagnostic imaging. Manufactured by Subtle Medical Inc. in Menlo Park, CA, this breakthrough solution aims to enhance patient care and boost the efficiency of radiology workflows in hospitals and clinics throughout Europe. The collaboration between Bracco Imaging and Subtle Medical underlines a shared commitment to advancing the field of imaging and improving healthcare outcomes for patients worldwide.

For more information about AiMIFY™ and Bracco's comprehensive range of diagnostic imaging products, please visit Bracco Imaging’s website.