Medtronic (NYSE:MDT) announced on Tuesday that the U.S. FDA cleared its SmartGuard algorithm as an interoperable automated glycemic controller, allowing the integration of its MiniMed 780G insulin pump with the Instinct glucose sensor developed by Abbott (NYSE:ABT).
The company identified the Instinct sensor, which comes with a wear time of up to 15 days, as the world’s thinnest integrated continuous glucose monitoring system.
The related compliance documentation required to complete the regulatory process is expected to take a few weeks, after which the companies intend to accept orders for the Instinct-integrated MiniMed 780G.
Concurrently, Medtronic (NYSE:MDT) announced the FDA approval of MiniMed 780G for people older than 18 years with insulin-requiring type 2 diabetes. The product is already available in the U.S. for type 2 diabetes with MDT’s Guardian 4 sensor, and pre-orders for its use with the Simplera Sync sensor will be accepted later this month.
The approvals come at a time when Medtronic (NYSE:MDT) plans to spin off its diabetes unit, as MiniMed, within the next 15 months.