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The Federal Trade Commission has agreed to the sale of Tornier’s U.S. rights and assets related to its total ankle and total silastic toe joint replacements to Integra Lifesciences. The move came ahead of a vote by Wright Medical Group and Tornier to combine. Read More
When communicating with FDA staff, it is vital that sponsors respond to agency questions during the timeframe requested, or they risk getting a hold letter with additional requests. Read More
France’s Agence nationale de sécurité du medicament et des produits de santé is looking for external experts to help assess the benefits and risks of health products, including medical devices. Read More
The UK’s healthcare costs regulator has decided not to back three new blood tests that are intended to speed the identification of bloodstream bacteria and fungi for routine use in the National Health System. Read More
President Barack Obama signed a measure last week to fund the federal government at fiscal year 2015 levels through Dec. 11, averting a government shutdown. Read More
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