CLAIM #40810 · Medtronic PLC (MDT) · 2026Q3 earnings call · Feb 17, 2026 · due Nov 30, 2026
“Finally, our MiniMed Fit patch pump remains on track, and we intend to submit it to the U.S. FDA by this fall.”
Thierry Pieton · CFO
How to check this claim
Look at: Submission of MiniMed Fit patch pump to U.S. FDA (regulatory filing status)
It came true if: Company confirms MiniMed Fit patch pump submitted to FDA by November 30, 2026
Where: Company press release, earnings call commentary, or SEC filing (10-Q/10-K) disclosing regulatory submission status
In context
“kets, but we also saw acceleration in the U.S. with strong sequential lift driven by Simplera Sync and Instinct, which both just launched in December. Our Diabetes business continues its strong innovation cycle, supported by multiple recent regulatory and pipeline milestones. In addition to introducing Instinct and Simplera to the market, we secured several FDA clearances that further expands 780G's indications. We also announced that 780G system is now available through pharmacy with agreements that cover the majority of commercially insured lives in the U.S. And we submitted MiniMed Flex to the U.S. FDA and began the U.S. pivotal study for Vivera, our third-generation fully closed loop algorithm, which we believe will help maintain our leadership in delivering industry-leading outcomes. Finally, our MiniMed Fit patch pump remains on track, and we intend to submit it to the U.S. FDA by this fall. The planned separation of MiniMed is perfectly on track. Our preferred path continues to be a 2-step, IPO and split. We continue to expect the separation to be complete by the end of calendar year '26. Now turning to the financials. This quarter, revenue of $9 billion grew 8.7% reported and 6% organic, a 50-basis-point acceleration from prior quarter and 50 basis points above our guidance. Geographically, this performance was balanced, led by high single-digit growth in Western Europe, with mid-single-digit growth across the U.S. and Japan. U.S. growth was 6% year-over-year, the strongest performance we've delivered since fiscal year 2019, excluding COVID compns. In China, we delivered low single-digit growth while navigating ongoing but manageable volume-based procurement in a few busine”
Verify independently
SEC filings for MDT ↗ · Claim quote is verbatim from the 2026Q3 earnings call.