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“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
CDRH will now publish a Federal Register notice and post “Immediately in Effect” guidance on its website when it changes its scientific expectations for a product under development, according to a final standard operating procedure that took effect Wednesday. Read More
Sponsors of 510(k)s for electrosurgical devices and bipolar electrosurgical vessel sealers intended for general surgery should test the biocompatibility of all materials that will come into contact with the patient, a pair of FDA guidances recommend. Read More