Medtronic and Abbott Achieve Critical Milestone in Diabetes Collaboration with FDA Approvals for MiniMed™ 780G and Instinct Sensor Integration

2025Year9Month2Day，Medtronic (NYSE:MDT) Announced that itsMiniMed™ 780GSystem Obtained by the United StatesFDATwo Key Regulatory Approvals Further Expand the Diabetes Management Technology Portfolio:

• SmartGuard™ Algorithm as an Interoperable Automatic Blood Glucose Controller (iAGC) approved, can be used with AbbottInstinctSensor integration, for1Type 2 Diabetes Management;

• MiniMed™ 780GSystem indications expanded to include those requiring insulin treatment.2Adult patients with type diabetes,Becoming the first dietary test applicable to this population™ Technology Automatic Insulin Delivery (AID) System.

  
  

This timeiAGCApproval Marks Medtronic CompletionFDAPre-market Approval (PMA) Path, AchieveInstinctSensor andMiniMed™ 780GClosed-loop integration of the system.InstinctThe sensor, developed by Abbott, is the world's smallest and thinnest integrated continuous glucose monitor (iCGM), supporting up to15Wear daily, designed for automated insulin delivery (AID) and Smart Multi-Dose Injection (MDI) System Optimization Design.

FDAApproval for UseMiniMed™ 780GSystem becomes the first to meet the standards of the American Diabetes Association (ADA) Standards of CareAIDSystem, applicable to intensive insulin therapy2Type diabetes patients. Endocrinology expert at University Hospitals Cleveland, OhioNatalie BelliniStated: "This approval extends the benefits of automated insulin delivery to2"Type diabetes population, reducing their daily management burden."

Currently publishedClinical ResearchAlreadyVerify System Effectiveness:

• Key Trial (n=95): UseGuardian™ 4AndSimplera Sync™ Sensor Patients,HbA1cReduce0.7%(Baseline7.9%), Glucose Range Time (TIR) Increase to81%(Baseline72%), with extremely low incidence of hypoglycemia.

  
  

• IMPACT2DResearch (n=236）：90During the period of using the closed-loop system,A1CFrom7.7%Decrease to6.9%，TIRFrom76.4%Increase to84.9%，Below the threshold (<70 mg/dL) Time only0.3%, the quality of life of patients has significantly improved.

  
  

Executive Vice President of Medtronic's Diabetes BusinessQue DallaraSaid: "Through integrationInstinctSensors and expand the system to2Type 2 diabetes, we are advancing an intelligent drug delivery ecosystem to provide patients with more options and a seamless experience. Existing customers will have priority access to integrated solutions through innovative programs."

Executive Vice President of Abbott's Diabetes Care BusinessChris ScogginsEmphasized: "Abbott's biowearable technology and MedtronicAID"The systematic integration will further simplify diabetes management and reduce the mental burden on patients."

MiniMed™ 780GThe system currently supportsGuardian™ 2Sensors, and will add this monthSimplera Sync™ Option. Medtronic Plans to Submit510(k)Apply, Seek2License for Type Diabetes Interoperable Pumps to Enable Future Integration withInstinctIntegration of sensors.