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New device registries should only be launched if they are the least burdensome way to meet scientific objectives, AdvaMed says in a revised document on registry principles released Tuesday. Read More
Devicemakers should note whether changes to PMA devices were due to enhancement, product complaints or adverse events when preparing annual reports for the FDA, new guidance released Friday says. Read More
Young children with diabetes have a new treatment option, thanks to the FDA’s approval of the Dexcom G4 Platinum continuous glucose monitoring system for children as young as two. Read More
Smith & Nephew has agreed to acquire ArthroCare for $1.5 billion, a move that could spur other orthopedic acquisitions by major players, an analyst says. Read More
Industry hopes that new Russian device regulations would speed up the pace of registrations and approvals have paled as regulators struggle to create implementing guidance. The regulations took effect in January 2013, but have yet to be fully enacted. Read More
Four employees of a medical device company who pleaded guilty to withholding side effect information in an IDE got off relatively easy in their settlement agreements, attorneys say. Read More
A year-long effort to refine CDRH’s research mission and get more bang for the buck is showing positive results, but one goal — using metrics to track success — remains elusive, Director Jeffrey Shuren told a gathering of the FDA’s Science Board. Read More
The FDA will create a device-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
An HHS final rule permitting patients direct access to their laboratory test reports will not have many direct consequences for Dx makers, but could result in more patients blaming manufacturers for incorrect test results, an industry expert says. Read More