FDA Approves Medtronic’s Disposable CGM
Medtronic also announced it has entered a global partnership with Abbott in an effort to expand CGM device options for patients living with diabetes.
The FDA approved a new disposable continuous glucose monitor (CGM) from medical device company Medtronic, according to a release.1 The Simplera is an all-in-one CGM that is half the size of the company’s previous devices, which allows for easier insertion and a simplified wear experience without the need for overtape.
FDA Approves Medtronic’s Disposable CGM / Halfpoint - stock.adobe.com
The Simplera CGM is meant to be used as part of a smart multiple daily injection system, which features the company’s smart insulin pen InPen and the Simplera Sync sensor. This platform is designed to be integrated with the MiniMed 780G system, an insulin pump that offers real-time insulin adjustments and corrections throughout a 24-hour period.
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In the release, Medtronic said that the Simplera Sync sensor is currently under review by the FDA as part of a separate filing and is not yet approved for commercial use. The company also added that the approval of the Simplera CGM “lays the groundwork” for an eventual submission of an updated version of the InPen app, which will be integrated with the CGM. The company will initiate a limited release once the app is cleared by the FDA.
In addition to the approval of the Simplera CGM, Medtronic also said that it has entered a global partnership with Abbott. The partnership will see the 2 companies collaborate on an integrated CGM based on Abbott’s FreeStyle Libre platform in an effort to expand CGM device options for patients living with diabetes.2
"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,” Que Dallara, executive vice president and president at Medtronic Diabetes, said in a release.1 “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.”
Under the original equipment manufacturer agreement, Abbot will provide a CGM to Medtronic that will work with Medtronic’s smart dosing devices and software across its automated insulin delivery and smart multiple daily injection systems. The systems will be sold only by Medtronic.
"This partnership pairs two global leaders in glucose sensing technology and insulin delivery," Jared Watkin, executive vice president of Abbott's diabetes care business said in a release.1 "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."
READ MORE: Continuous Glucose Monitoring Resource Center
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