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Cardiologists will be looking to Europe for pipeline updates this year, particularly on Thoratec’s HeartMate III and HeartWare’s MVAD pump, analysts say. Read More
Amgen could not certify to an FDA inspector that it had evaluated a contractor that serviced its equipment, according to a recent warning letter. Read More
Baxter Healthcare landed an FDA warning letter that includes multiple repeat observations and issues related to test methods, CAPAs and over-infusion with its elastomeric infusion systems. Read More
A recent decision by the Centers for Medicare & Medicaid Services to give devicemakers extra time to submit detailed reports under the Physician Payment Sunshine Act could lead to complacency, an industry attorney warns. Read More
Devicemakers should take steps now to secure a production account for submitting electronic Medical Device Reports, ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. Read More
The timeline for a bipartisan agreement to repeal the Medicare sustainable growth rate formula is a little less uncertain as it failed to make it into the debt ceiling bill passed Tuesday. Read More
Thousands of liability claims alleging the NuvaRing combination product contraceptive causes potentially fatal venous thromboembolisms are set to be settled with a $100 million Merck payout. Read More
CDRH plans to reduce the number of IDEs requiring more than two cycles to make a determination by 25 percent by Sept. 30, and by 50 percent by June 30, 2015. The aim is to get the median time for full IDE approvals down to 30 days by June 30, 2015. Read More