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A Swedish court has put temporary brakes on an order from the country’s Medical Products Agency that would require Medtronic to halt sales and recall its MiniMed 640G insulin pump. The stay will remain in place as Medtronic appeals the regulator’s actions before another court. Read More
The FDA inspector noted that design validation for the Xpert MRSA diagnostic test did not ensure that the device conforms to defined user needs and intended uses. Read More