Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.

MedTech Dive January 2, 2025
Elise Reuter

Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the many challenges with developing devices for children and infants.

A collaboration between a children’s hospital and the Food and Drug Administration aims to address challenges in developing medical devices for children and infants.

Children’s National Hospital in Washington, D.C., struck a five-year research collaboration with the FDA’s Office of Science and Engineering Laboratories (OSEL) to build regulatory science tools to help evaluate pediatric devices.

The partners will use de-identified clinical data, multimodal imaging and machine learning to develop open-source tools that can be used to design and test devices more efficiently.

Currently, few high-risk devices are labeled for pediatric use,...

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