MiniMed (NASDAQ: MMED) announced FDA clearance for its MiniMed Flex insulin pump, a smartphone-controlled device that is approximately half the size of the company's previous MiniMed 780G system.

The screenless pump features the SmartGuard adaptive algorithm with Meal Detection technology and includes a 300-unit insulin reservoir. The device is controlled through a mobile app compatible with iOS and Android devices and is cleared for individuals ages 7 and older with type 1 diabetes, and those 18 years and older with insulin-requiring type 2 diabetes.

At commercial launch, MiniMed Flex will support the company's sensor portfolio, including the Simplera Sync sensor and Abbott's Instinct sensor. The pump works with MiniMed's infusion set portfolio, including the Extended infusion set with up to 7 days of wear.

"MiniMed Flex embodies that promise. It's designed to work quietly and reliably in the background — advanced automation wrapped in a compact, smartphone-controlled pump," said Que Dallara, chief executive officer of MiniMed.

The company also announced the MiniMed Forward Program, which allows customers who purchased a MiniMed 780G system between February 18, 2026, and the launch date to upgrade to the MiniMed Flex system at no cost.

MiniMed plans to begin the launch with a customer experience phase this spring involving select current customers, followed by a broader commercial launch planned for the summer. Real-world results have demonstrated 80% Time in Range with recommended settings, according to the company.

The announcement comes one week after MiniMed's initial public offering as a standalone company.