Medtronic has obtained a pair of major green lights from the FDA for its flagship insulin pump—opening up the MiniMed 780G to adults with Type 2 diabetes in the U.S. and allowing it to connect with a new continuous glucose sensor made specially by Abbott.
The 15-day Instinct sensor is based on Abbott’s FreeStyle Libre line of wearable CGMs and is the result of a collaboration announced last year. Designed for people with Type 1 diabetes, it will link with Medtronic’s SmartGuard dosing algorithm, which operates as an interoperable automated glycemic controller—while the MiniMed 780G claimed an FDA clearance of its own earlier this year as an alternate controller-enabled pump, or ACE, to complete the tripartite setup.
According to the company, Medtronic and Abbott only need to finalize compliance documentation before they begin rolling out the combined sensor and pump for sale in the coming weeks, with existing customers having initial access.
Instinct will also launch alongside Medtronic’s latest Simplera Sync CGM, which will soon be taking preorders after receiving an FDA approval this past April.
For people with Type 2 diabetes, the MiniMed 780G system—which scored an approval in Europe in July—is currently available with Medtronic’s previous Guardian 4 sensor and will connect to the Simplera Sync. The company said it plans to submit new applications to the FDA for clearance as an interoperable insulin pump, which would then allow it to incorporate the Instinct.
“By enabling integration with the Instinct sensor and expanding the MiniMed 780G system to people with type 2 diabetes, we are advancing a smart dosing ecosystem designed to provide greater choice and flexibility, along with a more seamless experience,” said Que Dallara, head of Medtronic’s diabetes division—and CEO-to-be once it completes its spinout as an independent company.
“We're excited to expand our ecosystem of solutions under one roof with service our customers can count on around the clock,” Dallara added.
The new diabetes company will also wear the MiniMed moniker and will feature more than 8,000 global employees and a $2.8 billion portfolio spanning CGMs, pumps, smart insulin pens and more. Medtronic said it aims to complete the split by late 2026.