Smaller all-in-one CGM system approved for people living with diabetes
Manufacturer announces latest device approved is half the size of previous CGM tech.
A new disposable all-in-one continuous glucose monitoring (CGM) device has been approved in the US.
Medtronic has announced their latest Simplera CGM was recently approved by the Food and Drug Administration in the US.
The device is half the size of previous designs produced by the company, offering discretion and simplification for users with diabetes as the insertion and wear experience offered by the device removes the need to use overtape.
The Simplera device features latest CGM technology and is designed to be used as part of a Smart MDI system with the InPen smart insulin pen and the Simplera Sync sensor, which is designed to be integrated with the MiniMed 780G system.
The Simplera CGM and Simplera Sync sensor are CE (Conformité Européene) marked in Europe and launched earlier this year.
Following the recent FDA approval, on clearance the device will be launched in the US, with a limited market release in the US beginning with existing standalone CGM and InPen customers. The Simplera Sync sensor is under review by the FDA in a separate regulatory filing. It is investigational in the US and not approved for commercial use.
Additional global regulatory submissions and approvals of the CGM and sensor devices are pending.
The CGM approval coincides with manufacturer Medtronic’s announcement of a global partnership with Abbott to expand CGM options for people living with diabetes.
Under this agreement, the companies will collaborate on an integrated CGM based on Abbott's most advanced CGM platform.
Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and Smart MDI systems.
These systems, including the Abbott-based CGM, will be sold exclusively by Medtronic.
Medtronic expects this original equipment manufacturer (OEM) agreement to be accretive to Diabetes revenue and neutral to Diabetes gross margin. Additional financial terms of the partnership and timing for commercial availability were not disclosed.
Que Dallara, executive vice president and president, Medtronic Diabetes, said: “Our partnership with Abbott allows us to expand access to our advanced automated insulin delivery and Smart MDI systems that deliver best-in-class outcomes with the most widely used CGM in the world. We look forward to offering our Simplera platform alongside this integrated CGM to bring more choice to people living with diabetes within one seamless Medtronic experience.”
Medtronic continues to advance its pipeline for people requiring intensive insulin delivery, including next-generation durable and patch automated insulin delivery systems, smart pens, CGMs, algorithms, software and services and will continue to expand therapy indications.
Jared Watkin, executive vice president of Abbott's diabetes care business, said “This partnership pairs two global leaders in glucose sensing technology and insulin delivery. Abbott's CGM technology has set the standard for accurate, accessible, easy-to-use and reliable continuous glucose monitoring. Connecting this CGM built for Medtronic's advanced insulin delivery systems and algorithms makes it easier for people to spend less time thinking about their diabetes and more time living."
For more information about using CGM technology and eligibility speak to your diabetes healthcare professional
Medtronic and Abbott are among the sponsors of DRWF educational event United Through Diabetes – for more information and registration click here
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