7. Device Update


FDA approves the smart sensor,that connects insulin pens

FDA approves the smart sensor, Mallya that connects insulin pens

      Mallya from Biocorp is a smart sensor that is directly connected to insulin pen injectors, making them connected devices. It automatically collects and records important treatment information on selected insulin units, dates, and the time of injection and transmits it to a digital application. Mallya becomes the first system approved in the U.S. capable of automatically connecting different types of insulin and GLP-1 drugs. It is also the only device of its sort to be CE-marked as a Class IIb medical device. The initial version of Mallya is compatible with SANOFI’s Solostar pen injectors.



FDA approves Dexcom G7

FDA approves Dexcom G7

      The food and drug administration (FDA) has approved the Dexcom G7 for use by people with diabetes aged 2 and up, as well as during pregnancy. G7 is approximately 60% smaller than G6 and can be inserted on the abdomen, back of the upper arm, or, for children ages 2–17, on the upper buttocks. It provides advantages, such as allowing patients to customize alarm thresholds and reduce diabetes distress due to the fatigue they feel from frequent alarms. The Dexcom CGM app and the CLARITY app have been combined into one app for G7 users. The device has a life-span of 10 days, a shorter warm-up period of 30 minutes, and requires no fingerstick calibration. G7 has a MARD of 8.2% for those wearing the device on their upper arm.


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