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FDA Leader Looks To International Effort On Pediatric Device Development

 
• By Elizabeth Orr

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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