Irish healthcare technology company Medtronic has received the US Food and Drug Administration (FDA) approval for its Simplera continuous glucose monitor (CGM).
Simplera is the company’s first disposable, all-in-one CGM, measuring half the size of its previous CGMs, and is designed to simplify the insertion and wear experience.
Medtronic said the Simplera platform features its latest CGM form factor, and comprises Simplera CGM, used as part of a Smart MDI system.
Simplera CGM is used with the InPen smart insulin pen and the Simplera Sync sensor, which is designed to be combined with the MiniMed 780G system.
Both Simplera CGM and Simplera Sync sensor received the CE mark in Europe and were launched earlier this year, with positive remarks on ease of use, said the company.
Medtronic Diabetes executive vice president and president Que Dallara 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.”
In addition to the FDA approval, Medtronic has entered a global partnership with US-based medical device maker Abbott to expand its CGM options for people living with diabetes.
Under the partnership, the two companies will jointly work on an integrated CGM based on Abbott’s advanced CGM platform, FreeStyle Libre technology.
Abbott will provide FreeStyle Libre technology, which will be connected with Medtronic’s smart dosing devices and software, including automated insulin delivery (AID) and smart insulin pen systems.
Medtronic will exclusively commercialise the CGM systems integrated with Abbott’s technology, under the original equipment manufacturer (OEM) agreement.
Abbott diabetes care business executive vice president Jared Watkin 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.”
