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The FDA has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. Read More
In an acquisition worth up to $860 million, Covidien is integrating Israeli gastrointestinal devicemaker Given Imaging into its medical device business. Read More
National coverage policies on laser procedures and Xenon scans are among 10 of the policies the Centers for Medicare and Medicaid Services (CMS) may get rid of under a new procedure for dropping outdated National Coverage Determinations (NCDs). Read More
Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. Read More
The Centers for Medicare & Medicaid Services’ (CMS) final rule on the end-stage renal disease prospective payment system (PPS) assuages some industry concerns about the 2014 payments for ESRD facilities, an attorney says. Read More