Medtronic wins CE mark for Guardian 4 Sensor and InPen MDI smart insulin pen

Medtronic announced today that it received CE mark approvals for its InPen smart insulin pen and its Guardian 4 sensor.

Fridley, Minn.-based Medtronic’s new European approvals cover expanded functionality of the InPen for multiple daily injections (MDI), along with approval for the Guardian 4 sensor that requires no fingersticks for calibration or diabetes treatment decisions, according to a news release.

CE mark allows for the next-generation Guardian 4 sensor to be integrated with InPen or with the MiniMed 780G insulin pump system, or for standalone continuous glucose monitoring (CGM) use. Medtronic plans to begin the European commercial launches for the newly approved technologies in the fall. In the U.S., Guardian 4 and Minimed 780G are currently under investigational use only and are not approved for sale.

By combining Guardian 4 with MiniMed 780G, users will have automatically adjusted and correct insulin delivery every five minutes without fingersticks, the company said.

InPen, touted by Medtronic as the first and only smart insulin pen approved in Europe that’s integrated with real-time CGM through a smartphone app, can combine with Guardian 4 to provide real-time glucose readings and alerts alongside insulin dose information.

The smart MDI system automatically records insulin doses, tracks active insulin and recommends mealtime and correction doses based on its auto-populated bolus calculator, Medtronic said. Instead of having to switch between mobile applications, users can see all their information in real-time in one view to make dosing decisions and glucose management easier.

“We know that diabetes is a very personal journey, and we want to meet people where they are with solutions that fit their lifestyle and needs while enabling them to experience seamless support through all their life transitions. That’s why we’ve made the commitment to expand our portfolio and prioritize what matters most to our customers — a technology experience that’s easy but doesn’t compromise the outcomes they deliver,” Medtronic EVP & president of its diabetes business Sean Salmon said in the release. MassDevice