MiniMed Go^TM is
FDA cleared

Important Safety Information: MiniMed Go App  (InPen + Instinct + Simplera) 

The MiniMed Go app is intended for use with the InPen smart insulin pen and either Instinct continuous glucose monitoring (CGM) sensor or Simplera CGM to aid in diabetes management through multiple daily injections of compatible rapid-acting insulins (Humalog, Novolog, or Fiasp). The app and system components each require a prescription. When used with Instinct CGM, the app is indicated for patients ages 7 years and older, or patients ages 2 to 6 years under the supervision of an adult caregiver. When used with Simplera CGM, the app is indicated for patients ages 18 and over. If using InPen alone, the app is intended for all ages, with patients under age 7 requiring supervision. Use of these systems requires, among other things, adequate hearing and vision, a compatible mobile device and operating system, an open app, adequate pairing and connectivity, proper setting, use of an approved rapid-acting insulin, mobile device battery power, proper settings, accurate manual logging of insulin doses administered by means other than InPen, and occasional blood glucose meter (BGM) readings. Establishment of settings and treatment decisions should be made in consultation with a healthcare professional and on the basis of a combination of glucose readings, trend arrows, glucose target, active alerts, and recent events (such as insulin doses, exercise, meals, and medications). Failure to observe these and other details as found in the user guides can result in incorrect dosing, missed alerts and notifications, and ultimately hypoglycemia or hyperglycemia, with serious injury or death possible. For complete details, consult the appropriate system and component user guides, and see https://bit.ly/GoSafety.