FDA approves next-generation CGM with two-step insertion process
Click Here to Manage Email Alerts
Key takeaways:
- The Simplera CGM features a one-hand, two-step insertion process for the sensor that does not require additional tape.
- The FDA-approved device is part of Medtronic’s smart multiple daily injection system.
FDA approved Medtronic’s next-generation continuous glucose monitor for people with diabetes, according to an industry press release.
The Simplera CGM (Medtronic) is a CGM that is about half the size of prior Medtronic devices. According to the release, it is Medtronic’s first disposable CGM. The system features a two-step insertion process with a sensor that does not require the user to tape the device in place.
Simplera is designed to be used as part of a smart multiple daily injection system alongside Medtronic’s InPen smart insulin pen and its Simplera Sync sensor. According to the Medtronic website, the smart system will allow users to track insulin and glucose data to provide real-time insulin dosing guidance. The system is designed for integration with the Medtronic MiniMed 780G system.
According to the press release, Medtronic plans to submit an updated InPen app for FDA approval, which would allow it to be integrated with the Simplera CGM. Medtronic stated it plans a limited market release of the smart multiple daily injection system beginning with existing CGM and InPen users once the FDA grants clearance. The Simplera Sync sensor is being reviewed separately by the FDA and is not yet approved for commercial use, according to the release.
In addition to the Simplera CGM approval, Medtronic announced a partnership with Abbott to collaborate on an integrated CGM. The device will be based on Abbott’s CGM platform and will work exclusively with Medtronic’s smart dosing devices and software across automated insulin delivery and smart multiple daily injection systems. The systems will be sold exclusively by Medtronic, according to the release.
"Our partnership with Abbott allows us to expand access to our advanced automated insulin delivery and smart multiple daily injection systems that deliver best-in-class outcomes with the most widely used CGM in the world,” Que Dallara, executive vice president and president of Medtronic Diabetes, said in the release. “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.”
“Abbott's CGM technology has set the standard for accurate, accessible, easy-to-use and reliable CGM,” Jared Watkin, executive vice president of Abbott's diabetes care business, said in the release. “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."
Reference:
- Medtronic Diabetes announces CE Mark for new Simplera CGM with disposable all-in-one design. Available at: https://news.medtronic.com/2023-09-21-Medtronic-Diabetes-announces-CE-Mark-for-new-Simplera-TM-CGM-with-disposable-all-in-one-design. Published Sept. 21, 2023. Accessed Aug. 7, 2024.
- Smart MDI system. Available at https://www.medtronic-diabetes.com/en-gb/SmartMDI. Accessed Aug. 7, 2024.
Collapse
Read more about
Click Here to Manage Email Alerts