Diabetes management device MiniMed 780G receives FDA approval for integration with Abbott's Instinct Sensor and authorization for use in Type 2 diabetics.
The US Food and Drug Administration (FDA) has approved Medtronic plc's latest diabetes device, the MiniMed 780G system. This advanced technology is expected to be available in the United States this fall of 2023.
Medtronic Diabetes, a division of the global healthcare technology company, is committed to revolutionising diabetes management. Their focus is on next-generation sensors, intelligent dosing systems, and data science.
The MiniMed 780G system is designed to make diabetes more predictable, offering always-on support when and how people need it. This system has been approved for use in adults 18 years and older with insulin-requiring type 2 diabetes.
The system's success is backed by clinical evidence. In a recently published pivotal trial, participants experienced a 0.7% reduction in HbA1c and an increase in Time in Range to 81%, with minimal hypoglycemia. Furthermore, in a separate single-arm study, A1C decreased from 7.7% to 6.9%, and Time in Range increased from 76.4% to 84.9% during 90 days of advanced hybrid closed-loop use with low time-below-range (70 mg/dL) of 0.3%.
The SmartGuardTM algorithm, an integral part of the MiniMed 780G system, has been cleared as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, designed exclusively by Abbott for MiniMedTM automated insulin delivery (AID) and Smart MDI systems. The Instinct sensor is the world's smallest, thinnest, most discreet integrated CGM (iCGM) and offers a wear time of up to 15 days.
Medtronic plc plans to submit 510(k) applications seeking clearance for an interoperable pump indicated for type 2 diabetes. This would enable future integration with the Instinct sensor, further enhancing the system's capabilities.
Medtronic Diabetes has been pioneering first-of-its-kind innovations for over 40 years. With a mission to make diabetes more predictable for everyone, they deliver innovative technologies that transform the lives of two people every second. The company employs over 95,000 people across more than 150 countries and is headquartered in Galway, Ireland.
Medtronic plc's products include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. The company has announced two FDA regulatory milestones for its MiniMedTM 780G system, marking a significant step forward in diabetes management.
In partnership with Abbott, Medtronic plans to complete their required compliance documentation enabling sensor integration and marketing in the coming weeks. This collaboration aims to provide a more integrated and seamless diabetes management experience for users.
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