We heard you: a message from Que Dallara

I wanted to personally reach out regarding the recent approval of our Simplera Sync™ sensor. While this should have been a moment of celebration, I understand many of you were disappointed by our communication. Over the past few days, I’ve had the privilege of speaking with many of you and listening to your concerns.

I know you’re eager to access our Simplera Sync™ sensor, but supply is limited. This means making tough decisions. Our teams are working to ramp up supply, but inventory will remain limited. Because of that, we'll have a waitlist and as a customer, you'll have the option to be included. This change means we will not be prioritizing new hardware customers.

We’re also refreshing our CGM portfolio by partnering with Abbott. We plan to launch this CGM in the U.S. first and today, we announced an important milestone towards making this a reality — we submitted for FDA clearance.

If you choose to wait for the Abbott CGM^†, you will be enrolled in our Innovations Program so that you can place your order first once we receive FDA clearance. You will then be able to software upgrade or purchase a new pump in order to use either Simplera Sync™ or the Abbott CGM. But, to make this possible, we have to wait to get FDA clearance and we need to increase our Simplera Sync™ supply, too.

Whichever option you choose, there’s no action needed now. What’s important is that the choice is yours. When we’re ready to start taking Simplera Sync™ orders in early fall, we’ll let you know details on how to choose. And when we can, we’ll provide a comparison of refreshed sensor options with more details so you can decide what’s best for you.

Please know we’re working tirelessly to deliver an updated CGM experience. We’re grateful for your patience — and your feedback. Thanks for the opportunity to do better.
 

Footnote
† Investigational. Not cleared by the FDA for any use and not commercially available in the US.