US FDA Approves Medtronic's Simplera Sync Sensor for MiniMed 780G System

Apr 21, 2025

Digital health innovation, Chronic disease technology, US FDA, FDA approval, Diabetes care
Digital health innovation, Chronic disease technology, US FDA, FDA approval, Diabetes care

Source: Pharmabiz

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The US Food and Drug Administration (FDA) has approved Medtronic’s Simplera Sync sensor for use with its MiniMed 780G insulin delivery system, marking a significant leap in automated diabetes management. This advancement expands continuous glucose monitoring (CGM) options for people living with diabetes by offering more flexibility, no fingersticks, and simpler application.

Key Highlights

New Sensor Extends CGM Line

  • Simplera Sync is a single-device, disposable sensor that never needs fingersticks or overtape.

  • It has a quick two-step insertion and is designed for the MiniMed 780G system.

  • US launch in Fall 2025 is the plan.

Increased Features for MiniMed 780G

  • Meal Detection technology and adaptive insulin dosing every 5 minutes are included with the 780G system.

  • It has a "treat to target" strategy, with glucose targets as low as 100 mg/dL, allowing near-physiological control of glucose.

  • Compatible with 7-day infusion sets, eliminating the hassle of multiple injections per day.

Real-World Impact

  • Users around the world using the MiniMed 780G with best-settings have achieved in excess of 70% time-in-range on a consistent basis, surpassing global benchmarks.

  • The sensor and system combination allows for automated correction of insulin even when meals or snacks are not taken or underestimated.

Quotes by Medtronic Leadership
What Dallara, EVP and President of Medtronic Diabetes, stated:
"Our MiniMed 780G system provides sophisticated diabetes technology for so many people globally, and we're looking forward to building on this experience with the Simplera Sync sensor."Medtronic's Simplera Sync approval marks a new era in automated and streamlined diabetes management. With real-time adaptive insulin delivery coupled with easy-to-use design, Medtronic looks to eliminate daily hassles from patients and enable them to live life without breaks. With the diabetes technology competition heating up, the adoption of AI-driven capabilities and wearable technology is revolutionizing long-term disease management worldwide.

Digital health innovation
Chronic disease technology
US FDA
FDA approval
Diabetes care
Digital health innovation
Chronic disease technology
US FDA
FDA approval
Diabetes care

US FDA Approves Medtronic's Simplera Sync Sensor for MiniMed 780G System

Apr 21, 2025

Digital health innovation, Chronic disease technology, US FDA, FDA approval, Diabetes care
Digital health innovation, Chronic disease technology, US FDA, FDA approval, Diabetes care

Source: Pharmabiz

The US Food and Drug Administration (FDA) has approved Medtronic’s Simplera Sync sensor for use with its MiniMed 780G insulin delivery system, marking a significant leap in automated diabetes management. This advancement expands continuous glucose monitoring (CGM) options for people living with diabetes by offering more flexibility, no fingersticks, and simpler application.

Key Highlights

New Sensor Extends CGM Line

  • Simplera Sync is a single-device, disposable sensor that never needs fingersticks or overtape.

  • It has a quick two-step insertion and is designed for the MiniMed 780G system.

  • US launch in Fall 2025 is the plan.

Increased Features for MiniMed 780G

  • Meal Detection technology and adaptive insulin dosing every 5 minutes are included with the 780G system.

  • It has a "treat to target" strategy, with glucose targets as low as 100 mg/dL, allowing near-physiological control of glucose.

  • Compatible with 7-day infusion sets, eliminating the hassle of multiple injections per day.

Real-World Impact

  • Users around the world using the MiniMed 780G with best-settings have achieved in excess of 70% time-in-range on a consistent basis, surpassing global benchmarks.

  • The sensor and system combination allows for automated correction of insulin even when meals or snacks are not taken or underestimated.

Quotes by Medtronic Leadership
What Dallara, EVP and President of Medtronic Diabetes, stated:
"Our MiniMed 780G system provides sophisticated diabetes technology for so many people globally, and we're looking forward to building on this experience with the Simplera Sync sensor."Medtronic's Simplera Sync approval marks a new era in automated and streamlined diabetes management. With real-time adaptive insulin delivery coupled with easy-to-use design, Medtronic looks to eliminate daily hassles from patients and enable them to live life without breaks. With the diabetes technology competition heating up, the adoption of AI-driven capabilities and wearable technology is revolutionizing long-term disease management worldwide.

Share:

Digital health innovation
Chronic disease technology
US FDA
FDA approval
Diabetes care
Digital health innovation
Chronic disease technology
US FDA
FDA approval
Diabetes care