FDA Leader Looks To International Effort On Pediatric Device Development

Collaboration with Japan and Europe could help ease the development path for pediatric devices, cardiovascular device office director Bram Zuckerman said at a recent conference. Zuckerman also spoke on other cardiac device priorities at the FDA.

3D illustration of an anatomical model of the heart against a dark blue background.
• Source: Shutterstock

Getting advanced medical devices to children has long been a challenge for device companies. Economic considerations are at the heart of the issue; while pediatric devices are expensive to develop, the population that will ultimately benefit from them is small. As a result, clinicians must either improvise with adult technology or choose from a short list of aging devices cleared for pediatric indications.

But that may be changing, a senior US Food and Drug Administration official said at the recent Cardiovascular Research Technologies...

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