Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

“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.

Recommended Reading FDA defends Shuren’s tenure after report raises ethics concerns The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of ...

“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.

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. In a new ...

EBR Systems (ASX:EBR) announces the US FDA has accepted its final premarket approval application for the WiSE CRT System.

Pfizer withdraws OXBRYTA after post marketing studies showed that the risks of side effects were greater than the benefits.

The withdrawal comes after postmarketing studies showed that the risks of side effects were greater than the benefits.

British scientists have hailed the US approval of a new drug for schizophrenia, saying it “has the potential to change the ...

Answers Pet Food and Darwin’s Natural Pet Products, were found to have produced pet food that was contaminated with the ...

The U.S. Food and Drug Administration has approved Elanco Animal Health's skin disease treatment for dogs, the health ...

An on-demand video of “Everyone’s Targeting Seafood – CBP Forced Labor, Proposition 65, PFAS, and FDA” is available free for ...