New Simplera Sync™ sensor for the MiniMed™ 780G System now FDA approved
Medtronic (NYSE: MDT) has received FDA approval for its Simplera Sync™ sensor for use with the MiniMed™ 780G system. The new disposable, all-in-one sensor requires no fingersticks with SmartGuard™ and features a simplified two-step insertion process.
The MiniMed™ 780G system's adaptive algorithm automatically adjusts glucose levels every 5 minutes using Meal Detection™ technology. Real-world data shows users achieve time in range above 70% when using optimal settings. The system works with the world's only 7-day infusion set, reducing injections by 96% compared to daily injections.
A launch of the Simplera Sync™ sensor in the U.S. is scheduled for fall 2025. Currently, the MiniMed™ 780G system operates with the Guardian™ 4 sensor.
Medtronic (NYSE: MDT) ha ottenuto l'approvazione della FDA per il suo sensore Simplera Sync™, da utilizzare con il sistema MiniMed™ 780G. Il nuovo sensore monouso, tutto in uno, non richiede punture sul dito grazie a SmartGuard™ e presenta un processo di inserimento semplificato in due passaggi.
L'algoritmo adattivo del sistema MiniMed™ 780G regola automaticamente i livelli di glucosio ogni 5 minuti utilizzando la tecnologia Meal Detection™. I dati reali mostrano che gli utenti raggiungono un tempo in range superiore al 70% con impostazioni ottimali. Il sistema funziona con il set di infusione da 7 giorni, l'unico al mondo, riducendo le iniezioni del 96% rispetto alle iniezioni giornaliere.
Il lancio del sensore Simplera Sync™ negli Stati Uniti è previsto per l'autunno 2025. Attualmente, il sistema MiniMed™ 780G utilizza il sensore Guardian™ 4.
Medtronic (NYSE: MDT) ha recibido la aprobación de la FDA para su sensor Simplera Sync™ para su uso con el sistema MiniMed™ 780G. El nuevo sensor desechable, todo en uno, no requiere punciones en los dedos gracias a SmartGuard™ y cuenta con un proceso de inserción simplificado en dos pasos.
El algoritmo adaptativo del sistema MiniMed™ 780G ajusta automáticamente los niveles de glucosa cada 5 minutos utilizando la tecnología Meal Detection™. Los datos del mundo real muestran que los usuarios alcanzan un tiempo en rango superior al 70% al usar configuraciones óptimas. El sistema funciona con el único set de infusión de 7 días en el mundo, reduciendo las inyecciones en un 96% en comparación con las inyecciones diarias.
El lanzamiento del sensor Simplera Sync™ en EE.UU. está programado para el otoño de 2025. Actualmente, el sistema MiniMed™ 780G opera con el sensor Guardian™ 4.
메드트로닉 (NYSE: MDT)은 MiniMed™ 780G 시스템과 함께 사용할 Simplera Sync™ 센서에 대해 FDA 승인을 받았습니다. 새로 출시된 일회용 올인원 센서는 SmartGuard™ 기능으로 손가락 채혈이 필요 없으며, 간소화된 2단계 삽입 과정을 특징으로 합니다.
MiniMed™ 780G 시스템의 적응형 알고리즘은 Meal Detection™ 기술을 사용해 5분마다 자동으로 혈당 수치를 조절합니다. 실제 데이터에 따르면 최적 설정 시 사용자의 혈당 목표 시간 비율이 70% 이상에 도달합니다. 이 시스템은 세계 유일의 7일 인퓨전 세트와 함께 작동해 일일 주사에 비해 주사 횟수를 96% 줄입니다.
Simplera Sync™ 센서는 미국에서 2025년 가을에 출시될 예정입니다. 현재 MiniMed™ 780G 시스템은 Guardian™ 4 센서와 함께 작동하고 있습니다.
Medtronic (NYSE: MDT) a obtenu l'approbation de la FDA pour son capteur Simplera Sync™ destiné à être utilisé avec le système MiniMed™ 780G. Ce nouveau capteur jetable tout-en-un ne nécessite pas de piqûres au doigt grâce à SmartGuard™ et présente un processus d'insertion simplifié en deux étapes.
L'algorithme adaptatif du système MiniMed™ 780G ajuste automatiquement les niveaux de glucose toutes les 5 minutes grâce à la technologie Meal Detection™. Les données du monde réel montrent que les utilisateurs atteignent un temps dans la cible supérieur à 70 % avec des réglages optimaux. Le système fonctionne avec le seul set d'infusion de 7 jours au monde, réduisant les injections de 96 % par rapport aux injections quotidiennes.
Le lancement du capteur Simplera Sync™ aux États-Unis est prévu pour l'automne 2025. Actuellement, le système MiniMed™ 780G fonctionne avec le capteur Guardian™ 4.
Medtronic (NYSE: MDT) hat die FDA-Zulassung für seinen Simplera Sync™ Sensor zur Verwendung mit dem MiniMed™ 780G System erhalten. Der neue Einweg-All-in-One-Sensor benötigt dank SmartGuard™ keine Fingerstiche und verfügt über einen vereinfachten zweistufigen Einführungsprozess.
Der adaptive Algorithmus des MiniMed™ 780G Systems passt die Glukosewerte alle 5 Minuten automatisch mit der Meal Detection™ Technologie an. Reale Daten zeigen, dass Nutzer mit optimalen Einstellungen eine Zeit im Zielbereich von über 70 % erreichen. Das System arbeitet mit dem weltweit einzigen 7-Tage-Infusionsset, was die Injektionen im Vergleich zu täglichen Injektionen um 96 % reduziert.
Der Start des Simplera Sync™ Sensors in den USA ist für Herbst 2025 geplant. Derzeit arbeitet das MiniMed™ 780G System mit dem Guardian™ 4 Sensor.
- FDA approval expands CGM portfolio with new sensor option
- System achieves >70% time in range in real-world data
- 96% reduction in injections with 7-day infusion set
- Automatic glucose correction every 5 minutes
- Simplified two-step insertion process with no fingersticks required
- launch indicates restricted initial availability
- Launch delayed until fall 2025
Insights
FDA approval of Simplera Sync sensor strengthens Medtronic's diabetes portfolio, expanding options for MiniMed 780G system users with launch planned for fall 2025.
The FDA's approval of Medtronic's Simplera Sync™ sensor represents a strategic enhancement to the company's diabetes management portfolio. This disposable, all-in-one continuous glucose monitoring (CGM) sensor specifically designed for the MiniMed™ 780G system brings valuable user-experience improvements including a simplified two-step insertion process and elimination of fingersticks when used with SmartGuard™ technology.
What's particularly notable about this development is how it strengthens Medtronic's competitive positioning in the growing CGM market. The MiniMed™ 780G system's core differentiators include its proprietary Meal Detection™ technology and adaptive algorithm that automatically anticipates and corrects glucose levels every 5 minutes. Real-world data demonstrates users achieve time-in-range above 70% with optimal settings, exceeding international targets.
The product roadmap indicates a U.S. launch in fall 2025, suggesting a phased commercialization strategy. While this timeline means revenue impact won't be immediate, it solidifies Medtronic's commitment to innovation in diabetes care—a key therapeutic area for the company.
This approval expands patient choice within Medtronic's ecosystem, as users can now select between the Guardian™ 4 sensor and Simplera Sync™ sensor. The enhanced flexibility could improve patient satisfaction and potentially increase adoption rates of Medtronic's integrated diabetes management platform.
For a company focused on diversified growth across multiple therapeutic areas, incremental innovations like this help maintain competitiveness in established markets while the company pursues breakthroughs in emerging technologies elsewhere in its portfolio.
Latest approval expands Medtronic CGM portfolio in the
GALWAY,
The Simplera Sync™ is a disposable, all-in-one sensor that requires no fingersticks* with SmartGuard™ or overtape and features a simple, two-step insertion process. It is the company's newest addition to its CGM portfolio, which expands options and provides greater flexibility for users.**
The MiniMed™ 780G system's adaptive algorithm automatically anticipates, adjusts, and corrects† glucose levels every 5 minutes, 24/7 – working around the clock so users can focus on what matters.§ It's the only system featuring Meal Detection™ technology‡, which detects rising sugar levels and delivers more insulin as needed to help users keep glucose levels in range more often – even when users occasionally forget to dose insulin for snacks or meals or underestimate their carbs. The system uses a "treat to target" approach and flexible glucose targets as low as 100 mg/dL, which, combined with its adaptive algorithm allows it to more closely mirror the glucose levels of someone not living with diabetes. Real-world data of the system shows global users consistently achieve time in range above international targets of
"We're committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day," said Que Dallara, EVP and president of Medtronic Diabetes. "Our MiniMed™ 780G system delivers advanced diabetes technology for so many around the world, and we're excited to continue evolving this experience with expanded CGM options —including our Simplera Sync™ sensor, which we look forward to bringing to people living with diabetes in the
A limited launch of the Simplera Sync™ sensor will begin in the
About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,
*Fingersticks required in manual mode & to enter SmartGuard. If symptoms don't match alerts & readings, use a fingerstick. Refer to user guide. Pivotal trial participants spend avg of >
**Participants in a clinical trial reported the sensor was smaller and lighter than other sensors they have used. Data on file: CIP330, N=243, ages 2-80.
†Refers to auto correct, which provides bolus assistance. Can deliver all correction doses automatically without user interaction, feature can be turned on and off.
‡Taking a bolus 15 – 20 minutes before a meal helps to keep blood sugar levels under control after eating.
§ Refers to SmartGuard™ feature. Individual results may vary.
- Choudhary P. et al, Lancet Diabetes Endocrinol. 2022; https://doi.org/10.1016/ S2213-8587(22)00245-5
- Arrieta A, et al. Diabetes Obes Metab. 2022;10.1111/dom.14714
- Matejko B, et al. Diabetes Care 2022;45:2628–2635
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SOURCE Medtronic plc
FAQ
When will the Simplera Sync sensor be available for the MiniMed 780G system (MDT)?
What are the key features of the new Simplera Sync sensor for MDT's MiniMed 780G system?
How often does the MiniMed 780G system (MDT) adjust glucose levels?
What is the time in range achievement for MiniMed 780G system users (MDT)?
How does the MiniMed 780G system's infusion set compare to daily injections (MDT)?
