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MITA Participates in FDA’s AI Workshop

MITA is participating in the Food and Drug Administration (FDA) public workshop, “Evolving Role of Artificial Intelligence in Radiological Imaging,” to engage interested parties on the rapidly expanding impact of Artificial Intelligence (AI) in the medical imaging space. The event features presentations from MITA Members and others who will review the importance of regulatory frameworks that ensure AI technologies are developed in a way that advances Quadruple Aim goals – enhancing patient experience and clinical satisfaction, improving outcomes, and reducing costs.

During the two-day workshop, participants will discuss challenges and opportunities created from emerging AI software algorithms within medical imaging. MITA Members will lead presentations on a broad range of issues, including the growing impact of AI on breast cancer screening mammography, ultrasound, and other common medical tests. While acknowledging that ensuring the smooth delivery of innovative radiological AI software to the patient bedside will be challenging, industry leaders strongly encourage the FDA to utilize existing regulatory clearance pathways that have already proved effective for clearing AI algorithms.

“The potential for AI in medical imaging is enormous, and the FDA will play an important role in navigating how physicians and patients will ultimately benefit,” said Dennis Durmis, SVP – Radiology Head of Americas Region, Bayer, and Chair of the MITA Board of Directors. “It is timely that the Agency encourages innovation by supporting regulatory frameworks that are predictable, transparent, and fair to all interested parties.”

Along with advocating for consistent regulatory oversight rooted in industry Standards and best practices, MITA participants are also emphasizing the need to ensure emerging AI technologies can be trusted to safeguard patient privacy and security. As a shared responsibility among manufacturers, providers, and other parties, protecting the data of patients who come in contact with AI radiological imaging software is critical.

MITA Member participants include Nikos Gkanatsios, Ph.D. Senior Director, Systems Engineering and QA, Hologic; Richard Frank MD, Ph.D, Chief Medical Officer, Siemens Healthineers; Marc Edgar, Ph.D, Senior Information Scientist, GE Global Research; Benny Lam Ph.D, Principal Regulatory Affairs Specialist, AI/DH Regulatory Intelligence, Philips Ultrasound; Mike Washburn, Chief Engineer, GE Healthcare – Ultrasound; Rob Trahms, Artificial Intelligence Leader, Philips Healthcare; Scott Paulson, Sr. Director of Regulatory Affairs and Quality Systems; Compliance Officer, FUJIFILM SonoSite; Tony Roder, Regulatory Affairs Executive, GE Healthcare; and Andy Milkowski, Ph.D, Research and Technology Manager, Ultrasound, Siemens Healthineers.

“We are greatly encouraged by the opportunity to participate in this important event and engage with Agency professionals and other interested parties. We look forward to working with the FDA to advance the adoption of AI technologies while supporting Quadruple Aim goals,” Durmis concluded.

The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is a collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit www.medicalimaging.org.

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