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CLAIM #40759 · Medtronic PLC (MDT) · 2026Q2 earnings call · Nov 18, 2025 · due Nov 30, 2026

And with FIT, our AID patch system, we intend to submit to the U.S. FDA by the fall of next year.

Thierry Pieton · CFO

PENDING
graded after results covering Nov 30, 2026 are reported

How to check this claim

Look at: FDA submission status for MiniMed FIT AID patch system

It came true if: Company confirms FDA submission for FIT has been made by fall 2026 (by end of November 2026)

Where: management commentary on earnings calls / company press releases

In context

wth in the back half of the fiscal year. Our diabetes business is in a strong innovation cycle. We've had a lot of great news in the last few months as our teams execute on the pipeline. In July, the 780 gs system received CE Mark for three expanded indications, including for type two, for children as young as age two, and during pregnancy. In September, the US FDA also approved 780 gs for people with type two diabetes. And they cured our smart guard algorithm enabled integration with the Instinct sensor. Earlier this month, we received FDA approval to start The U.S. Pivotal for Vivera, our third-generation algorithm. We also continue to make progress with our new AID systems, MiniMed Flex, and MiniMed Fit. Remain on track to submit Flex, our next-generation durable pump, to the U.S. FDA. And with FIT, our AID patch system, we intend to submit to the U.S. FDA by the fall of next year. Look, finally, our planned separation of MiniMed is on track. 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. So we have a lot of momentum with diabetes given the order inflection, and progress on the pipeline and separation. And you're hearing today that this momentum acceleration extends across the enterprise. As we advance our pipeline and deliver growth. Now turning to the financials. The second quarter revenue of $9 billion grew 6.6% reported and 5.5% organic. That's an acceleration from last quarter and 75 basis points ahead of the midpoint of our guidance. Our revenue from geographic from a geographic perspective was balanced, with double-digit growth in Japan, and mid-single-digit gro

Verify independently

SEC filings for MDT · Claim quote is verbatim from the 2026Q2 earnings call.