FDAnews Device Daily Bulletin

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and keep pace with increasingly global operations.

The European Commission has asked the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) to provide an opinion on the potential health impacts caused by DEHP (di(2-ethylhexyl) phthalate)-containing medical devices.

From the moment President Barack Obama March 23, 2010, signed the Patient Protection and Affordable Care Act, Americans have been left to sort out the winners and losers.

Making a unique effort, around 20 small scale medical device manufacturers have drawn up plans to set up a common component manufacturing facility near Ahmedabad, India.

Kane Biotech, a biotechnology company engaged in the development and commercialization of products that prevent and remove microbial biofilms, is pleased to announce the issuance of patent no. 4999842 entitled “Antimicrobial compositions for inhibiting growth and proliferation of a microbial biofilm on medical devices” by Japan’s patent office.

The SEC filed a civil injunctive action charging Revolutions Medical and the company’s CEO with fraudulently issuing false and misleading press releases concerning the company’s flagship product, a retractable, medical safety syringe.

We may not have a Prometheus-style surgery pod on our hands just yet, but doctors across the globe are slowly beginning to embrace other types of robots in the operating room.

Merit Medical Systems announced that it has received 510(k) clearance from the FDA to market the Merit Laureate hydrophilic guide wire.