Drug Delivery Business News, reports today that the FDA granted two major approvals that will broaden access to the MiniMed 780G system.
First, the FDA granted clearance for its SmartGuard algorithm as an interoperable automated glycemic controller (iAGC). This enables integration with the Abbott Instinct sensor, designed specifically through a collaboration between the medtech giants. Second, the FDA approved MiniMed 780G for adults with insulin-requiring type 2 diabetes, making it the latest automated insulin delivery system given the green light to expand to this broad patient population.
These milestones widen the addressable market for the Medtronic Diabetes business, which the company plans to separate in the next 15 months or so. The company announced in May that it planned to separate the Diabetes unit into a standalone, publicly traded company.