STAT+: FDA's new head of device safety held senior role at company troubled by safety warnings

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.

“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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