MiniMed Flex cleared

The FDA just cleared the MiniMed Flex — a smartphone‑controlled insulin pump with an adaptive algorithm for children and adults with type 1 or insulin‑requiring type 2 diabetes, marking a push toward phone‑first diabetes devices. (patientcareonline.com)

MiniMed Flex is roughly half the footprint of the company’s MiniMed 780G and about the size of two stacked insulin vials while carrying a 300‑unit insulin reservoir. (prnewswire.com) The device is a screenless pump designed to be managed through a mobile app with software updates delivered via iOS and Android at launch. (prnewswire.com) At commercial release Flex will support MiniMed’s Simplera Sync sensor and Abbott’s Instinct sensor, and it works with MiniMed’s Extended infusion set that the company says can be worn up to seven days and reduce injections by up to 96% versus traditional insulin therapy. (prnewswire.com) Under the hood Flex runs MiniMed’s SmartGuard™ algorithm with Meal Detection™ technology, which the company cites as having demonstrated roughly 80% Time in Range in real‑world results using recommended settings. (prnewswire.com) The clearance sets specific age limits: the device is cleared for people with type 1 diabetes aged 7 years and older and for people with insulin‑requiring type 2 diabetes aged 18 years and older, according to the company’s announcement dated March 18, 2026. (ng.investing.com) (investing.com) (prnewswire.com) MiniMed created a Forward Program that allows customers who bought a MiniMed 780G system between February 18, 2026 and the Flex launch date to upgrade to Flex at no cost, and the company plans a select customer experience phase this spring followed by broader commercial availability in summer. (ng.investing.com) (investing.com) (prnewswire.com) The announcement arrived one week after MiniMed’s initial public offering, with MiniMed shares beginning trading on Nasdaq under the ticker MMED in early March and Medtronic retaining roughly a 90.03% stake after the offering closed on March 9, 2026. (prnewswire.com) (news.minimed.com)

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