FDA’s new head of device safety held senior role at company troubled by safety warnings

By Lizzy Lawrence

Sept. 20, 2024

FDA Reporter

The Food and Drug Administration has tapped Ross Segan, a former device industry exec and Army veteran, to lead its division charged with ensuring medical device safety. 

Segan was chief medical officer at Olympus from 2020 to 2023. Olympus is a leading distributor of endoscopes and the recipient of FDA warning letters claiming the company did not adequately address product defects — including instances where endoscope caps fell into patients’ bodies.

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“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeffrey Shuren, head of FDA’s medical devices center, at the time. 

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   Lizzy Lawrence

   FDA Reporter

   Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter.

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