MiniMed is out to prove it deserves the name, with a new FDA clearance for its smallest insulin pump yet.
At about half the size of the company’s mainstay 780G pump, the MiniMed Flex is described as roughly two insulin vials stacked on top of each other. Designed to be discreet, it does away with an onboard screen in favor of being largely controlled from the user’s smartphone.
According to MiniMed, when it makes its commercial debut, the Flex will connect with the company’s Simplera Sync continuous glucose monitor as well as the new Instinct sensor made by Abbott, in addition to seven-day infusion sets.
Carrying a 300-unit insulin reservoir, the pocket-sized Flex will also employ the SmartGuard dosing algorithms and meal detection features touted by the 780G. The FDA’s clearance covers its use in Type 1 diabetes for ages 7 and up and in Type 2 diabetes for people 18 years and older.
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“It’s designed to work quietly and reliably in the background—advanced automation wrapped in a compact, smartphone‑controlled pump,” said MiniMed CEO Que Dallara, who now helms Medtronic’s former diabetes division following its spinout from the medtech giant earlier this month. “The result is technology that lets people spend less time managing diabetes and more time living their lives.”
“Securing FDA clearance for our first product as a standalone, public company—just one week after our IPO—marks a major milestone and underscores our commitment to delivering the breakthrough innovation our customers deserve,” Dallara said in a statement.
This month also saw the newly independent MiniMed collect a European approval for the combination of its 780G pump and the Instinct CGM, with its 15-day sensor built on Abbott’s FreeStyle Libre wearable platform.
MiniMed’s Nasdaq IPO closed March 9, netting about $538 million, with Medtronic retaining about 90% ownership of the company.
