Medical device recalls for May 2014
June 3, 2014 by MassDevice staff
May Summary
Class I recalls: 9
Class II recalls: 137
Class I recalls
Date Posted, Recalling Manufacturer, Trade Name/Product, Reason for Recall Read more
Diabetes: Medtronic wins CE Mark for MiniMed Duo
June 3, 2014 by Brad Perriello
Medtronic today said it won CE Mark approval in the European Union for its MiniMed Duo combination glucose sensor and insulin infusion set.
Touting the device as the world’s 1st to combine continuous glucose monitoring with a body-worn infusion set, Medtronic said it’s planning a launch for MiniMed Duo into the European market as soon as local regulatory authorities give it the green light. Read more
Diabetes: DexCom wins FDA approval for professional glucose monitor
June 4, 2014 by Brad Perriello
DexCom said it won pre-market approval from the FDA for its Dexcom G4 Platinum Professional continuous glucose monitor, touting it as the only professional-version CGM to offer real-time, unblinded feedback for patients and caregivers.
Patients use the G4 Platinum Professional CGM for 7 days as the device logs the rate and direction of glucose changes every 5 minutes. Read more
Unique Device Identifiers: 4 tips for compliance
June 4, 2014 by Arezu Sarvestani
Deadlines are fast approaching for medical device makers to unveil their Unique Device Identifier compliance programs and, if last year’s survey results are any indication, many companies are unprepared.
When PricewaterhouseCoopers surveyed more than 300 industry participants last year, less than 1 in 5 said they were prepared for UDI implementation and 19% said that they had not even started planning their UDI programs. Read more
HeartWare reveals FDA warning letter
June 4, 2014 by Brad Perriello
HeartWare International said today that the FDA issued a warning letter yesterday over procedures at a plant in Miami Lakes, Fla.
Framingham, Mass.-based HeartWare said the warning letter flagged 4 observations logged during an inspection of the Miami Lakes facility in January. Read more