Medtronic Diabetes announces FDA clearance for MiniMed Go™ Smart MDI system featuring Instinct sensor made by Abbott

Core Insights - Medtronic has received FDA 510(k) clearance for its MiniMed Go™ Smart MDI system, which integrates insulin dosing and glucose data into a single app, aimed at improving diabetes management for individuals on multiple daily injections [1][2]. Product Overview - The MiniMed Go™ system combines the InPen™ smart insulin pen and Abbott's Instinct sensor, providing real-time glucose data, dose calculations, missed dose alerts, and actionable guidance [9]. - The system is designed for individuals aged 7 years and older with insulin-requiring type 1 and type 2 diabetes, and for children aged 2 to 6 under adult supervision [2]. Market Need - Over 15 million people globally rely on multiple daily injections for diabetes management, often facing challenges during mealtimes that can lead to diabetes distress [3]. - Missed boluses can significantly affect diabetes management, with just two missed doses a week potentially raising HbA1C levels by up to 0.4%, increasing the risk of complications [4]. Performance Data - Previous users of Medtronic's Smart MDI system experienced improvements in glycemic control, with Time in Range (TIR) increasing from 55.7% to 67.2% when responding to over 75% of missed dose alerts within an hour [5]. Company Vision - Medtronic aims to simplify diabetes management for individuals using injections by providing the benefits of automated insulin delivery systems, thereby reducing the burden of daily insulin dosing [6]. Features and Benefits - The MiniMed Go™ system includes missed dose alerts, a dose calculator for easier decision-making, action-oriented guidance for missed or miscalculated doses, and CareLink™ software for enhanced provider collaboration [7]. Launch Timeline - The commercial launch of the MiniMed Go™ system is expected to begin in the U.S. in the spring of 2026 [8]. Company Background - Medtronic is a leading global healthcare technology company focused on innovative solutions for various health conditions, including diabetes management, with a commitment to enhancing patient outcomes through advanced technology [12].