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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of the policies the Centers for Medicare and Medicaid Services (CMS) may get rid of under a new procedure for dropping outdated National Coverage Determinations (NCDs).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
Kiwi devicemakers are crying foul over proposed fee structures for the Australia New Zealand Therapeutic Products Agency (ANZTPA), saying they will stifle innovation among smaller medtech companies and limit access to new technologies. Read More
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
Devicemakers that operate in Brazil should be checking to see that none of their business holdings has been charged with corrupt practices — either in Brazil or elsewhere in the world, experts warned during a recent American Bar Association meeting devoted to the country’s new antibribery law. Read More
Devicemakers testing the Wi-Fi functionality of their products should simulate the radio frequency (RF) characteristics of a hospital and should use access points from different manufacturers, a recent white paper from Laird Technologies recommends. Read More
If some lawmakers get their way, the federal budget proposal for fiscal 2014 and 2015 now being negotiated will include a provision shielding FDA user fee revenue from any across-the-board sequestration cuts. Read More
A group of patients is asking for sanctions against Johnson & Johnson’s Ethicon unit following allegations the company destroyed thousands of documents related to ongoing pelvic mesh trials. Read More
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis. Read More
AngioDynamics is restructuring its operations in NY in order to focus on product rationalization, lean initiatives, supply chain optimization and enterprise resource planning. Read More