Medtronic has received the US Food and Drug Administration (FDA) approval for the integration of its MiniMed 780G system with Abbott’s Instinct sensor.
Designed by Abbott, the Instinct sensor is a compact, discreet continuous glucose monitor (CGM) that offers up to 15 days of wear time.
The regulatory approval enables the SmartGuard algorithm to operate as an interoperable, automated glycemic controller for individuals with type 1 diabetes.
The FDA approval is said to complete the pre-market approval process for integrating the Instinct sensor with its MiniMed 780G system for type 1 diabetes.
Medtronic and Abbott intend to finalise compliance documentation soon, enabling sensor integration and marketing.
Abbott diabetes care business executive vice president Chris Scoggins said: “We’re working together to do what’s best for people living with diabetes.
“Abbott’s biowearable technology has long set the standard for accurate, accessible, easy-to-use continuous glucose monitoring.
“Connecting it with the MiniMed 780G system aims to reduce the mental load of daily management, making it easier for people to live with diabetes.”
In addition, the US health agency approved the MiniMed 780G system for adults with insulin-dependent type 2 diabetes.
With the approval, MiniMed 780G becomes the first automated insulin delivery system with meal detection technology available for the type 2 diabetes population.
In the recent clinical trials, the system has shown improvements in glycemic outcomes and reduced treatment burdens for users.
Currently available with the Guardian 4 sensor, the MiniMed 780G system will also be available with the SimpliSafe Sync sensor, once pre-orders begin.
Medtronic intends to submit an FDA 510(k) application for an interoperable pump intended for type 2 diabetes, facilitating future integration with the Instinct sensor.
Medtronic Diabetes president and executive vice president Que Dallara said: “These milestones mark an important next step in our work to bring the proven performance and outcomes of our MiniMed 780G automated insulin delivery system to more people living with diabetes.
“By enabling integration with the Instinct sensor and expanding the MiniMed 780G system to people with type 2 diabetes, we are advancing a smart dosing ecosystem designed to provide greater choice and flexibility, along with a more seamless experience.
“We’re excited to expand our ecosystem of solutions under one roof with a service our customers can count on around the clock.”
