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Two breast implant manufacturers were served with warning letters after the FDA found they failed to comply with post-approval study requirements. Read More
The FDA ordered a Beverly Hills plastic surgeon to stop marketing an implantable pouch that the doctor says can help prevent a nasty side effect for women’s breast augmentations. Read More
International medical device associations rejected a recent report by the International Consortium of Investigative Journalists (ICIJ), which pointed to inadequate oversight of devices globally. Read More
Monteris is releasing a new version of its NeuroBlate probe to address a problem with overheating of its magnetic resonance-guided laser thermal therapy device. The new probe is equipped with a non-metallic fiber optic sensor. Read More
The agency learned that patients are sometimes being treated with medications that are not approved for use with an intrathecal implanted pump. Read More