NIBIB to Advance Pediatric Medical Device Development

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced the launch of the design phase of a public-private partnership (PPP) addressing the lack of medical devices designed and approved for children in the United States. This partnership highlights the need to include pediatrics in the development of all medical care, including medical imaging, diagnostics and interventions. Last year the American College of Radiology® (ACR®) provided comments to a Request for Information seeking input on the development of the Pediatric Medical Devices (PMD) PPP focusing on AI-enabled software as a medical device for pediatric radiology patients.

The design phase will include a plan to build and launch a partnership that will bring together the resources of federal agencies and private sector organizations, including industry and non-profits. This phase will be led by the Foundation for the National Institutes of Health. The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the NIBIB are leading this effort, with multiple other institutes and centers engaged through the NIH Pediatric Research Consortium. The cross-agency efforts include collaborations with the Center for Devices and Radiological Health at the U.S. Food and Drug Administration and the Division of Research, Innovation, and Ventures at the Biomedical Advanced Research and Development Authority

For more information, contact Katie Grady, ACR Government Affairs Director.