New Simplera Sync鈩� sensor for the MiniMed鈩� 780G System now FDA approved
Medtronic (NYSE: MDT) has received FDA approval for its Simplera Sync鈩� sensor for use with the MiniMed鈩� 780G system. The new disposable, all-in-one sensor requires no fingersticks with SmartGuard鈩� and features a simplified two-step insertion process.
The MiniMed鈩� 780G system's adaptive algorithm automatically adjusts glucose levels every 5 minutes using Meal Detection鈩� technology. AG真人官方-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鈩� sensor in the U.S. is scheduled for fall 2025. Currently, the MiniMed鈩� 780G system operates with the Guardian鈩� 4 sensor.
Medtronic (NYSE: MDT) ha ottenuto l'approvazione della FDA per il suo sensore Simplera Sync鈩�, da utilizzare con il sistema MiniMed鈩� 780G. Il nuovo sensore monouso, tutto in uno, non richiede punture sul dito grazie a SmartGuard鈩� e presenta un processo di inserimento semplificato in due passaggi.
L'algoritmo adattivo del sistema MiniMed鈩� 780G regola automaticamente i livelli di glucosio ogni 5 minuti utilizzando la tecnologia Meal Detection鈩�. 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鈩� negli Stati Uniti 猫 previsto per l'autunno 2025. Attualmente, il sistema MiniMed鈩� 780G utilizza il sensore Guardian鈩� 4.
Medtronic (NYSE: MDT) ha recibido la aprobaci贸n de la FDA para su sensor Simplera Sync鈩� para su uso con el sistema MiniMed鈩� 780G. El nuevo sensor desechable, todo en uno, no requiere punciones en los dedos gracias a SmartGuard鈩� y cuenta con un proceso de inserci贸n simplificado en dos pasos.
El algoritmo adaptativo del sistema MiniMed鈩� 780G ajusta autom谩ticamente los niveles de glucosa cada 5 minutos utilizando la tecnolog铆a Meal Detection鈩�. Los datos del mundo real muestran que los usuarios alcanzan un tiempo en rango superior al 70% al usar configuraciones 贸ptimas. El sistema funciona con el 煤nico set de infusi贸n de 7 d铆as en el mundo, reduciendo las inyecciones en un 96% en comparaci贸n con las inyecciones diarias.
El lanzamiento del sensor Simplera Sync鈩� en EE.UU. est谩 programado para el oto帽o de 2025. Actualmente, el sistema MiniMed鈩� 780G opera con el sensor Guardian鈩� 4.
氅旊摐韸鸽雼� (NYSE: MDT)鞚� MiniMed鈩� 780G 鞁滌姢韰滉臣 頃粯 靷毄頃� Simplera Sync鈩� 靹检劀鞐� 雽�頃� FDA 鞀轨澑鞚� 氚涭晿鞀惦媹雼�. 靸堧 於滌嫓霅� 鞚柬殞鞖� 鞓澑鞗� 靹检劀電� SmartGuard鈩� 旮半姤鞙茧 靻愱皜霛� 毂勴槇鞚� 頃勳殧 鞐嗢溂氅�, 臧勳唽頇旊悳 2雼硠 靷届瀰 瓿检爼鞚� 韸轨鞙茧 頃╇媹雼�.
MiniMed鈩� 780G 鞁滌姢韰滌潣 鞝侅潙順� 鞎岅碃毽鞚� Meal Detection鈩� 旮办垹鞚� 靷毄頃� 5攵勲雼� 鞛愲彊鞙茧 順堧嫻 靾橃箻毳� 臁办爤頃╇媹雼�. 鞁れ牅 雿办澊韯办棎 霐半ゴ氅� 斓滌爜 靹れ爼 鞁� 靷毄鞛愳潣 順堧嫻 氇╉憸 鞁滉皠 牍勳湪鞚� 70% 鞚挫儊鞐� 霃勲嫭頃╇媹雼�. 鞚� 鞁滌姢韰滌潃 靹戈硠 鞙犾澕鞚� 7鞚� 鞚疙摠鞝� 靹疙姼鞕� 頃粯 鞛戨彊頃� 鞚检澕 欤检偓鞐� 牍勴暣 欤检偓 須熿垬毳� 96% 欷勳瀰雼堧嫟.
Simplera Sync鈩� 靹检劀電� 氙戈淡鞐愳劀 2025雲� 臧�鞚勳棎 於滌嫓霅� 鞓堨爼鞛呺媹雼�. 順勳灛 MiniMed鈩� 780G 鞁滌姢韰滌潃 Guardian鈩� 4 靹检劀鞕� 頃粯 鞛戨彊頃橁碃 鞛堨姷雼堧嫟.
Medtronic (NYSE: MDT) a obtenu l'approbation de la FDA pour son capteur Simplera Sync鈩� destin茅 脿 锚tre utilis茅 avec le syst猫me MiniMed鈩� 780G. Ce nouveau capteur jetable tout-en-un ne n茅cessite pas de piq没res au doigt gr芒ce 脿 SmartGuard鈩� et pr茅sente un processus d'insertion simplifi茅 en deux 茅tapes.
L'algorithme adaptatif du syst猫me MiniMed鈩� 780G ajuste automatiquement les niveaux de glucose toutes les 5 minutes gr芒ce 脿 la technologie Meal Detection鈩�. Les donn茅es du monde r茅el montrent que les utilisateurs atteignent un temps dans la cible sup茅rieur 脿 70 % avec des r茅glages optimaux. Le syst猫me fonctionne avec le seul set d'infusion de 7 jours au monde, r茅duisant les injections de 96 % par rapport aux injections quotidiennes.
Le lancement du capteur Simplera Sync鈩� aux 脡tats-Unis est pr茅vu pour l'automne 2025. Actuellement, le syst猫me MiniMed鈩� 780G fonctionne avec le capteur Guardian鈩� 4.
Medtronic (NYSE: MDT) hat die FDA-Zulassung f眉r seinen Simplera Sync鈩� Sensor zur Verwendung mit dem MiniMed鈩� 780G System erhalten. Der neue Einweg-All-in-One-Sensor ben枚tigt dank SmartGuard鈩� keine Fingerstiche und verf眉gt 眉ber einen vereinfachten zweistufigen Einf眉hrungsprozess.
Der adaptive Algorithmus des MiniMed鈩� 780G Systems passt die Glukosewerte alle 5 Minuten automatisch mit der Meal Detection鈩� Technologie an. AG真人官方e Daten zeigen, dass Nutzer mit optimalen Einstellungen eine Zeit im Zielbereich von 眉ber 70 % erreichen. Das System arbeitet mit dem weltweit einzigen 7-Tage-Infusionsset, was die Injektionen im Vergleich zu t盲glichen Injektionen um 96 % reduziert.
Der Start des Simplera Sync鈩� Sensors in den USA ist f眉r Herbst 2025 geplant. Derzeit arbeitet das MiniMed鈩� 780G System mit dem Guardian鈩� 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鈩� 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鈩� 780G system brings valuable user-experience improvements including a simplified two-step insertion process and elimination of fingersticks when used with SmartGuard鈩� technology.
What's particularly notable about this development is how it strengthens Medtronic's competitive positioning in the growing CGM market. The MiniMed鈩� 780G system's core differentiators include its proprietary Meal Detection鈩� technology and adaptive algorithm that automatically anticipates and corrects glucose levels every 5 minutes. AG真人官方-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鈥攁 key therapeutic area for the company.
This approval expands patient choice within Medtronic's ecosystem, as users can now select between the Guardian鈩� 4 sensor and Simplera Sync鈩� 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鈩� is a disposable, all-in-one sensor that requires no fingersticks* with SmartGuard鈩� 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鈩� 780G system's adaptive algorithm automatically anticipates, adjusts, and corrects鈥� glucose levels every 5 minutes, 24/7 鈥� working around the clock so users can focus on what matters.搂 It's the only system featuring Meal Detection鈩� technology鈥�, which detects rising sugar levels and delivers more insulin as needed to help users keep glucose levels in range more often 鈥� 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. AG真人官方-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鈩� 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 鈥攊ncluding our Simplera Sync鈩� sensor, which we look forward to bringing to people living with diabetes in the
A limited launch of the Simplera Sync鈩� sensor will begin in the
About the Diabetes Business at听Medtronic听()
听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.
鈥燫efers to auto correct, which provides bolus assistance. Can deliver all correction doses automatically without user interaction, feature can be turned on and off.
听鈥aking a bolus 15 鈥� 20 minutes before a meal helps to keep blood sugar levels under control after eating.
听搂 Refers to SmartGuard鈩� feature. Individual results may vary.
- Choudhary P. et al, Lancet Diabetes听Endocrinol. 2022;听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鈥�2635
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Ashley Patterson | Ryan听Weispfenning听 |
Public Relations | Investor Relations听 |
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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)?
