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FDA Commissioner Scott Gottlieb said the agency is evaluating thousands of adverse event reports for Bayer’s permanent birth control device Essure received in the past year. Read More
The FDA posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
The recalled anchors were not implicated in any deaths and they do not pose any risk of embolization as they remained attached to the implant, the company said. Read More
Cyberattacks on medical imaging devices such as CT and MRI devices are poised to become a major challenge for device manufacturers, according to researchers at Ben Gurion University of the Negev, Israel. Read More
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
The firm’s CAPA procedures and lack of written MDR procedures were among the nonconformities flagged on more than one occasion after FDA inspections. Read More
In a rare exception to the FDA’s normal practice, the agency posted a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More