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  • Diabetes Monitoring Technology Moving Toward Consumer Convenience

    The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System.  According to Bloomberg, this device marks the first continuous glucose monitoring system that adults can use that does not use diagnosis via taking fingertip blood samples using a fingerstick. Traditionally, fingersticks required one to prick their finger to obtain blood droplets for diabetes monitoring devic ...
  • FDA Clears First Apple Watch Medical Device Accessory

    The FDA recently cleared the first medical device accessory for the Apple Watch -- AliveCor's KardiaBand.  According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG within 30 seconds and display the results on the Apple Watch or iPhone.  In conjunction with the KardiaBand, AliveCor is introducing "SmartRhythm, a new feature within the Kard ...
  • FDA Provides Guidance on 3D-Printed Medical Device Products

    The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices.  The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices currently on the market that are manufactured using 3D printers.  Importantly, many of these devices can be tailored to fit a specific patient’s anatomy.  For example, the ...
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