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Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More
A federal panel is recommending that the FDA retain regulatory authority over high-risk device software, while loosening regulations around two categories considered to be lower risk. Read More
“Accurate detection … is critically important in efforts to successfully detect and potentially reduce the incidence of cervical cancer,” Cepheid CEO John Bishop says. Read More
A new FDA report shows medical device recalls nearly doubled from fiscal year 2003 to 2013, but a greater focus on safety — not shoddier products — appears to be behind the rise. Read More
HHS’ health IT coordinator is calling for all electronic health records to incorporate the unique device identifiers of implantable devices by 2015. Read More
The U.S. could save about $30 billion in healthcare costs a year by requiring medical devices to be interoperable, a white paper by West Health Institute and the Office of the National Coordinator for Health IT concludes. Read More