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The FDA is seeking members for a new Patient Engagement Advisory Committee to provide input on issues related to the development of new treatment modalities. Read More
Stephen J. Ubl is stepping down as president and chief executive officer of AdvaMed effective Oct. 15, the association’s board of directors announced last week. Read More
The FDA hasn’t seen the expected number of industry participants in the Medical Device Single Audit Program pilot, and is hoping to attract volunteers as it eyes a Jan. 1, 2017, launch date. Read More
Citing recent reports of infection control lapses, the FDA and Centers for Disease Control and Prevention are advising healthcare facilities to ensure they are complying with device manufacturers’ instructions for reprocessing reusable devices. Read More
A Ukrainian national and his company have agreed to pay $30 million to settle with the U.S. government over civil charges of illegally profiting from stolen statements in a case that involved at least two devicemakers. Read More
A draft report from a nonprofit that focuses on cost-effectiveness in healthcare takes aim at St. Jude Medical’s CardioMEMS HF System, saying there is insufficient evidence indicating that the device represents a marked improvement over existing technologies. Read More
To reduce dosing errors that have resulted in deaths and patient adverse events, the FDA is providing manufacturers with labeling and safety testing recommendations for medical devices and combination products containing the blood thinner heparin. Read More
To reduce possible burn injuries, the FDA is recommending that manufacturers of magnetic resonance-conditional devices assess radio frequency-induced heating in MR environments. Read More
The Federal Trade Commission continues to try and put the brakes on Mentor, Ohio-based Steris’ proposed buyout of Synergy Health, claiming Synergy’s proposed strategy to use X-ray to sterilize medical products was abandoned in the wake of a commission investigation into the deal. Read More