MiniMed announces CE Mark approval of Instinct with MiniMed 780G  – 

MiniMed announced today that it has received CE Mark approval for use of the Abbott-partnered Instinct CGM with the MiniMed 780G system. This makes the AID system compatible with three CGMs: Guardian 4, Simplera Sync, and Instinct. With this availability, users now have access to a sensor with 15 days of wear, more than double that of Guardian 4 and Simplera Sync’s seven days. Medtronic first reported that it submitted Instinct for regulatory clearance in December 2025.

Commercial launch expected in summer 2026

MiniMed expects to launch Instinct with the MiniMed 780G in the first European markets this summer. In Europe, the MiniMed 780G system is indicated for individuals aged two years and older with T1D and insulin-requiring T2D who require at least six units of insulin per day. The system is also CE Marked in Europe for use during pregnancy, joining the CamAPS FX algorithm.

Instinct has seen expanded use and demand in the US

Instinct was first launched with MiniMed 780G in the US in December 2025. Ahead of its commercial availability, Medtronic reported strong demand: combined orders and pre-orders for Instinct and the newly launched Simplera Sync exceeded 35,000 in 3Q25.

MiniMed 780G use with the Instinct sensor was FDA-cleared in January, with continued coverage expansion

Regulatory and coverage momentum has also continued in the US. The FDA cleared the MiniMed Go app with InPen integration for use with the Instinct sensor in January. Medicare and Medicare Advantage now cover MiniMed 780G with the Instinct sensor, expanding CGM choice for older adults and further widening the system’s addressable population significantly. Medtronic also reported in January that it secured agreements with major pharmacy benefit managers (PBMs) and PBM group purchasing organizations (GPOs) to distribute MiniMed 780G with Instinct (and Simplera Sync) through the pharmacy channel. Together, these regulatory and commercial developments in the US and EU will support broader global uptake of the sensor.

Close Concerns’ Questions

  1. Instinct adoption in the US has undoubtedly compared positively to that of Simplera Sync; how are these CGM’s adoption rates expected to mix in the EU moving forward?
  2. Which international markets will Medtronic prioritize for the commercial launch of Instinct?
  3. Does Medtronic intend to make Instinct available as a standalone sensor?

-- by Jeremy Alkire, Monica Oxenreiter, and Kelly Close

MiniMed announces CE Mark approval of Instinct with MiniMed 780G -
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