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CooperVision’s Puerto Rico facility has received an FDA warning letter for inadequate investigations into nonconformities and other GMP issues. Read More
BALTIMORE — Devicemakers in the process of setting unique device identification codes with the FDA may want to bake in some extra time, agency officials say. Read More
Medicare spent a total of $1.9 billion in 2009 on 26 different tests and procedures that offered little or no health benefit, according to a new report by researchers at Harvard University, who found that a quarter of Medicare recipients received at least one of the services. Read More
Medtronic has settled a long-running global patent dispute with Edwards Lifesciences related to transcatheter aortic valve replacement programs, allowing the company to sell its CoreValve transcatheter valve. Read More
A recent court decision to broaden the scope of the Foreign Corrupt Practices Act could mean increased risks to devicemakers, one attorney says. Read More
The Centers for Medicare & Medicaid Services is broadening the scope of its prior authorization program for power mobility devices, expanding it geographically. The program determines whether items meet Medicare coverage requirements before they reach beneficiaries. Read More
The South Korean government is proposing strict quality controls to ensure the safety of unregistered devices distributed during public health emergencies. Read More
Abbott’s efforts to work with the Centers for Medicare & Medicaid Services to improve reimbursement for its MitraClip transcatheter mitral valve repair system have paid off with an advisory panel’s recommendation to cover the procedure. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More
As 3D printing gains popularity among medical devicemakers, the FDA wants to get advice from manufacturers and researchers to guide its product reviews and possibly future guidance. Read More