Eli Lilly Receives FDA 510K Clearance For Diabetes Management & Insulin Dosing App

Eli Lilly has received an FDA 510K clearance for new Go Dose diabetes management and insulin dosing apps for users and prescribers of their Humalog rapid-acting insulin. The app will support type 2 diabetes mellitus management by helping users review, analyze and evaluate historical blood glucose test readings. Go Dose (for consumers) and Go Dose Pro (for physicians) can be used with iPad or iPhone devices. No information is available regarding future apps for Android devices.

510K clearances are required for manufacturers to notify the FDA of their intent to market a medical device for properly identify the device . . .