New Guardian 4 sensors CE Marked

[everydayupsanddowns]

Was sent this earlier this week as part of a Medtronic group I belong to:

Dear friends,

We have wonderful news that we want you to be the first to know about. We’re thrilled to announce that our next generation continuous glucose monitoring (CGM), the new Guardian™ 4 Sensor is now CE Mark Approved.

Wondering what the CE mark approval means for you? CE marking indicates that the new Guardian™ 4 Sensor has been assessed and meets the European Union standards for safety, health and environmental protection.

Guardian™ 4 sensor is our latest sensor technology that requires no fingersticks*, no calibration & has a non-adjunctive label (sensor glucose readings can be used to make diabetes treatment decisions). Guardian™ 4 sensor is indicated for patients 7 years old or older and will be compatible with the MiniMed™ 780G insulin pump system, as well as being integrated with InPenTM insulin pen and for stand-alone CGM use.

We are working hard behind the scenes to ensure Guardian™ 4 Sensor is available late summer in most European & Middle Eastern countries. Availability may vary by country, based on regulatory approvals. Please be reassured we will communicate with you as soon as it’s available in your respective countries.

We really hope that with every step we take, being it in product innovation or in service innovation, we can make your everyday life with T1D easier and lighter.

*If glucose alerts and CGM readings do not match SG or expectations, use a blood glucose meter to make diabetes treatment decisions

 

[SB2015]

Thanks for posting this Mike

That is quite a bit sooner than was suggested when I started on the Guardian 3.
it will be interesting to see how this is rolled out, and whether we will ne to purchase a new transmitter or be switched across, or perhaps wait until it is time to renew the contract.

 

[everydayupsanddowns]

Yes there can sometimes be quite a delay between getting a CE mark, and the product becoming available in various countries, but it’s an important step towards getting your hands on it!