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The FDA is seeking a court order to force a retired dentist in South Dakota to pull the laser devices he manufacturers from the market, but the defendant maintains he has the right to sell the devices through a private membership association. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on conformity certificates issued by European notified bodies, under a government action plan unveiled Oct. 14. Read More
Hospira is recalling all of its GemStar Power Supply 3VDC units, used to power the GemStar Infusion Pump, because they may fail to deliver electric power to the pump. Read More
Software to help diabetics manage their condition has advanced significantly in recent years, but gaps in regulation and interoperability issues are hindering access, industry and patient groups told the FDA Thursday. Read More
The FDA wants additional data and a revised indication for use before it will approve an ultrasound treatment for prostate cancer, according to an unapprovable letter sent to French devicemaker EDAP. Read More