Medtronic (NYSE:MDT) said today that the separation of its MiniMed Diabetes unit remains on track as it advances the MiniMed Flex system.
On the company’s third-quarter earnings call, CFO Thierry Piéton explained the business’ performance as it works toward completing an IPO — for which it filed at the end of 2025 — and bringing new insulin pump technology to the market. (See the full results at MassDevice.)
According to Piéton, Medtronic submitted the next-generation MiniMed Flex to the FDA during the third quarter. The MiniMed Flex (8 series) pump is “much smaller than 780G,” allowing for more discrete placement while still using the same reservoirs and infusion sets. It will also work with both the Simplera Sync and Instinct sensors. The now-confirmed submission fell in line with the company’s plan to submit Flex to the FDA before the end of its fiscal year.
Meanwhile, Medtronic also began a U.S. pivotal study for Vivera, its third-generation algorithm for automated insulin delivery. It also remains set to submit its MiniMed Fit patch pump system to the FDA by the coming fall.
“Our Diabetes business continues its strong innovation cycle, supported by multiple recent regulatory and pipeline milestones,” Piéton said. “In addition to introducing Instinct and Simplera to the market, we secured several FDA clearances that further expand [MiniMed] 780G’s indications. We also announced that the 780G is now available through pharmacy agreements that cover the majority of commercially insured lives in the U.S.”
Overall performance by the Medtronic Diabetes business as IPO moves forward
The Diabetes business at Medtronic registered $796 million in revenue. That marked a 14.8% year-over-year increase for the unit.
According to Piéton, double-digit strength in international markets drove the business. It also saw acceleration in the U.S. thanks to drivers like Simplera Sync and Instinct, made by Abbott, which both launched in December.
Meanwhile, the planned separation of the business remains on the right path, the CFO said.
The medtech giant announced in May 2025 that it planned to separate the Diabetes unit into a standalone, publicly traded company. The move sought to create “a more focused Medtronic” with a more simplified portfolio in high-margin growth markets. At the same time, it creates an independent, scaled leader in diabetes, called MiniMed. Over the last nine months, Medtronic continues to state that the process — which it expected to complete within 18 months — is proceeding as planned.
It expects to get the IPO-driven separation done by the end of the calendar year.
“The planned separation of mini med is perfectly on track,” Piéton said. “Our preferred path continues to be a two-step, IPO and split. We continue to expect the separation to be complete by the end of calendar year ’26.”
On the Medtronic end, the company expects the separation to ultimately prove accretive. At the moment of the split, though, it anticipates some dilution.
