MiniMed submits its first patch pump for US regulatory approval, alongside advancements in automated insulin delivery and longer-lasting glucose sensors, signalling a potential shift in diabetes care innovation.
MiniMed has filed for US regulatory clearance for its first patch pump, a move that could broaden its diabetes technology line-up as the company pushes beyond its newly launched tubed device. The submission to the Food and Drug Administration is for MiniMed Fit, with a commercial debut planned for next summer, according to MedTech Dive.
The device is designed with a 300-unit insulin reservoir and up to seven days of wear, features MiniMed says could make it better suited to people with type 2 diabetes who need larger insulin doses and fewer device changes. Chief executive Que Dallara told investors the patch pump is part of a wider effort to build out the company’s portfolio after its spin-out from Medtronic earlier this year.
MiniMed is also advancing software that would automate insulin delivery more fully. The company has completed enrolment in a pivotal trial of a fully closed-loop algorithm, which would calculate insulin needs throughout the day even without meal announcements or carbohydrate counting. MiniMed plans to introduce that feature next year, if development and regulatory steps stay on track.
At the same time, the company is working on a new glucose sensor with longer wear time. MiniMed has received an investigational device exemption to begin a pivotal study this autumn, although it has not yet disclosed the target wear period or other technical details. The effort follows its 2024 deal with Abbott, under which Abbott agreed to supply a version of its glucose sensors that works only with MiniMed devices, helping address what Dallara described as a long-standing weakness in continuous glucose monitoring.
MiniMed also lifted its sales outlook, now expecting organic revenue growth of 10.5% for its 2027 fiscal year, which ends in April. The company said the upgraded forecast reflects stronger US demand for MiniMed Flex, its smaller tubed pump, and increasing adoption of its glucose sensors globally. MiniMed said US pump sales rose 20% year on year, while Flex has already secured Europe’s CE mark and is due to launch there in November.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
