FDA Approves Apple Watch App for Diabetes Patients

The US Food and Drug Administration has approved an Apple Watch app that can be used by diabetes patients to monitor their level of glucose.

The new Apple Watch app was designed and developed by a medical products company called DexCom, and according to it, the new app will help diabetics track and display the glucose levels on the watch’s screen in the form of a special graph.

The goal of the new app is to help patients diagnosed with diabetes to read their blood sugar levels by just looking at the app.

DexCom has designed the app with a monitor that uses a small sensor located under the skin. This sensor can measure the levels of glucose every five minutes so that diabetics will always know what their blood sugar is.

The new Apple Watch app will be available in April, around the same time Apple Watch will be put on sale.
Apple said that its first smartwatch will function both as a smart device and as a fitness and health tracker.
One of the challenges will be that some health apps and devices need to be approved by health officials.

The US Food and Drug Administration previously considered any software that is meant to measure the glucose level in diabetics as being Class 3. This means that the apps required the highest level of regulatory approval.

Recently, the FDA has revised its previous guidelines and the monitors developed by DexCom will be labeled as Class 3 devices.

However, the apps that only display data on smart mobile devices do not need any prior approval, but they need to be registered with the FDA and follow some of its rules.

This change of guidelines will benefit both Apple and the third-party app developers, which means that more health apps will be created for the upcoming Apple Watch without needing any regulatory approval.

The app that made the FDA reconsider its guidelines is NightScout, a software that uploads the data from the glucose monitor- developed by DexCom- on the internet and the patients can view it using their mobile devices.
Image Source: 9to5mac

Bio
Latest Posts

Christina Langfold

Remember that weird girl in school who never quite managed to fit in? Who was always silent and strange? That was me during my entire teenage life. A few years after finishing college (with a degree in arts) I decided that the best way to become more sociable, while also feeling safe, is to test my people skills online.