American healthcare technology company Medtronic has secured CE (Conformité Européenne) Mark approval for its new Simplera continuous glucose monitor (CGM) sensor.
Medtronic has designed the all-in-one, disposable Simplera with a simple, two-step insertion process and improved user experience.
The latest no-fingerstick sensor, which does not need over tape, works in tandem with the InPen smart insulin pen, which offers real-time, individualised dosing assistance to help make managing diabetes easier.
The new Simplera CGM works in conjunction with the InPen and provides customers meaningful insights that lessen guessing and challenging manual computations in diabetes care, the healthcare technology company said.
Medtronic Diabetes EVP and president Que Dallara said: “Despite the rapid adoption of CGM over the past decade, less than 30% of individuals on MDI therapy using a CGM achieve glycemic targets – highlighting a significant unmet need.
“We’re excited to help more people to reach their goals with our advanced algorithm in InPen powered by our smallest and most comfortable CGM to date.
“This newest addition of a Smart MDI solution to our holistic portfolio demonstrates our commitment to meeting people where they are in their diabetes journey with simplified solutions that help make life with diabetes easier.”
The Medtronic Smart MDI system is said to be the first to seamlessly combine a smart insulin pen that is powered by an algorithm that can be adjusted to provide individualised dose recommendations with a real-time CGM.
Simplera is recommended for ages two and up and is compatible with iOS and Android.
The sensor is only permitted for investigational usage in the US as it has not received US Food and Drug Administration (FDA) approval.
The next-generation sensor and automated insulin delivery (AID) system from Medtronic are not yet commercially accessible in the US or Europe.
