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Bold changes could be coming to New Zealand’s medical device market as the government maps out regulatory reforms roughly a year after the collapse of a long-anticipated trans-Tasman regulatory authority. Read More
The FDA hit Albany, N.Y., devicemaker CMP Industries with a warning letter for numerous GMP violations, including not adequately investigating rust-like particles in one of its products. Read More
The UK’s National Institute for Health and Care Excellence has recommended Siemens’ Virtual Touch Quantification device as a cost-effective method of detecting and monitoring liver damage in patients with chronic hepatitis B or C, compared with alternatives. Read More
The FDA hit Massachusetts-based NSC Pearson with a warning letter for marketing an attention deficit hyperactivity disorder system without marketing clearance or approval. Read More
Members of Vietnam’s National Assembly Standing Committee are urging caution as the government considers a draft decree to beef up management of medical devices. Read More
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