New Simplera Sync™ sensor for the MiniMed™ 780G System now FDA authorised

Newest approval expands Medtronic CGM portfolio within the U.S.

GALWAY, Eire, April 18, 2025 /PRNewswire/ — Medtronic plc (NYSE: MDT), a world chief in healthcare expertise, immediately introduced the U.S. Meals and Drug Administration (FDA) approval for the Simplera Sync™ sensor to be used with the MiniMed™ 780G system. With this approval, the MiniMed™ 780G system now gives extra flexibility for customers of the corporate’s most superior insulin supply system that includes Meal Detection™ expertise with each the Guardian™ 4 sensor and Simplera Sync™ sensor.

The Simplera Sync™ is a disposable, all-in-one sensor that requires no fingersticks* with SmartGuard™ or overtape and encompasses a easy, two-step insertion course of. It’s the firm’s latest addition to its CGM portfolio, which expands choices and offers better flexibility for customers.**

The MiniMed™ 780G system’s adaptive algorithm mechanically anticipates, adjusts, and corrects^† glucose ranges each 5 minutes, 24/7 – working across the clock so customers can give attention to what issues.^§ It is the one system that includes Meal Detection™ expertise^‡, which detects rising sugar ranges and delivers extra insulin as wanted to assist customers preserve glucose ranges in vary extra usually – even when customers often neglect to dose insulin for snacks or meals or underestimate their carbs. The system makes use of a “deal with to focus on” method and versatile glucose targets as little as 100 mg/dL, which, mixed with its adaptive algorithm permits it to extra intently mirror the glucose ranges of somebody not residing with diabetes. Actual-world knowledge of the system exhibits world customers persistently obtain time in vary above worldwide targets of 70% when utilizing optimum settings (energetic insulin time of two hours and 100 mg/dL goal glucose).^1-3 It is usually the one system that works with the world’s solely infusion set that lasts as much as 7 days in order that customers solely have to alter their infusion set as soon as per week and might expertise 96% fewer injections in comparison with a number of day by day injections.

“We’re dedicated to driving innovation that makes life simpler for these residing with diabetes to allow them to neglect about their diabetes as a lot as potential all through the day,” mentioned Que Dallara, EVP and president of Medtronic Diabetes. “Our MiniMed™ 780G system delivers superior diabetes expertise for therefore many all over the world, and we’re excited to proceed evolving this expertise with expanded CGM choices —together with our Simplera Sync™ sensor, which we stay up for bringing to folks residing with diabetes within the U.S.”

A restricted launch of the Simplera Sync™ sensor will start within the U.S. within the fall of 2025. In the present day, the MiniMed™ 780G system can be utilized with the Guardian™ 4 sensor.

In regards to the Diabetes Enterprise at Medtronic (www.medtronicdiabetes.com)
 Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering people to dwell life on their phrases, with essentially the most superior diabetes expertise and always-on help when and the way they want it. We have pioneered first-of-its-kind improvements for over 40 years and are dedicated to designing the way forward for diabetes administration by next-generation sensors (CGM), clever dosing programs, and the ability of knowledge science and AI whereas at all times placing the shopper expertise on the forefront.

About Medtronic
Daring considering. Bolder actions. We’re Medtronic. Medtronic plc, headquartered in Galway, Eire, is the main world healthcare expertise firm that boldly assaults essentially the most difficult well being issues going through humanity by looking for and discovering options. Our Mission — to alleviate ache, restore well being, and lengthen life — unites a world workforce of 95,000+ passionate folks throughout greater than 150 international locations. Our applied sciences and therapies deal with 70 well being situations and embrace cardiac gadgets, surgical robotics, insulin pumps, surgical instruments, affected person monitoring programs, and extra. Powered by our various data, insatiable curiosity, and want to assist all those that want it, we ship revolutionary applied sciences that remodel the lives of two folks each second, each hour, each day. Anticipate extra from us as we empower insight-driven care, experiences that put folks first, and higher outcomes for our world. In every part we do, we’re engineering the extraordinary. For extra data on Medtronic (NYSE: MDT), go to www.Medtronic.com and comply with Medtronic on LinkedIn.

*Fingersticks required in handbook mode & to enter SmartGuard. If signs do not match alerts & readings, use a fingerstick. Consult with consumer information. Pivotal trial members spend avg of > 93% in SmartGuard.
**Contributors in a medical trial reported the sensor was smaller and lighter than different sensors they’ve used. Knowledge on file: CIP330, N=243, ages 2-80.
†Refers to auto appropriate, which offers bolus help. Can ship all correction doses mechanically with out consumer interplay, function could be turned on and off.
 ‡Taking a bolus 15 – 20 minutes earlier than a meal helps to maintain blood sugar ranges below management after consuming.
 § Refers to SmartGuard™ function. Particular person outcomes could differ.

1. Choudhary P. et al, Lancet Diabetes Endocrinol. 2022;  S2213-8587(22)00245-5
2. Arrieta A, et al. Diabetes Obes Metab. 2022;10.1111/dom.14714
3. Matejko B, et al. Diabetes Care 2022;45:2628–2635

SOURCE Medtronic plc