Medtronic secures FDA clearance for MiniMed Go Smart MDI system

Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for its MiniMed Go Smart MDI system, a solution aimed at supporting individuals with insulin-requiring type 1 (T1D) and type 2 diabetes (T2D).

The MiniMed Go Smart MDI system combines the InPen smart insulin pen and Abbott’s Instinct sensor, with both linked via the MiniMed Go app.

The system provides personalised, real-time insights and actionable guidance.

Features include action-oriented guidance for missed or miscalculated doses, a dose calculator to simplify decision-making, missed dose alerts to help reduce glucose highs, and CareLink software reporting to facilitate collaboration between patients and healthcare providers.

The MiniMed Go system has received clearance for individuals aged seven and older with insulin-requiring T1D or T2D, and for children between two and six years old when supervised by an adult.

Globally, more than 15 million individuals depend on multiple daily injections to manage diabetes. Mealtime insulin dosing can be challenging and may lead to distress. Missed boluses can affect glycaemic outcomes; even missing two doses per week may increase HbA1C by up to 0.4%, which raises complication risks, said Medtronic.

Real-world data from users of Medtronic’s previous Smart MDI system showed improvements in glycaemic control when responding promptly to alerts. Time in Range (TIR) increased from 55.7% to 67.2% when more than 75% of missed dose alerts were addressed within an hour and rose to 71.5% when users responded to correct high glucose alerts with a bolus within an hour.

Medtronic diabetes EVP and president and MiniMed CEO-designate Que Dallara said: “For too long, people using injections have carried the weight of diabetes management without access to the algorithms that make automated insulin delivery systems so powerful.

“MiniMed Go is designed to change that, bringing the smarts of an AID [automated insulin delivery] system to individuals who prefer an insulin pen.”

Commercial launch of the MiniMed Go Smart MDI system in the US is expected in early 2026.

In December 2025, Medtronic commercially launched its MiniMed 780G system in the US, which was then integrated with Abbott’s Instinct sensor.

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