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An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. Read More
The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. Read More
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of the policies the Centers for Medicare and Medicaid Services (CMS) may get rid of under a new procedure for dropping outdated National Coverage Determinations (NCDs).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