Form 8-K · Current Report · Filed 2026-03-24
FDA Clears MiniMed Flex Insulin Pump, Impacting Medtronic's Q4 Guidance
Medtronic plc announced that the U.S. Food and Drug Administration (FDA) has cleared the MiniMed Flex, a next-generation insulin pump, several months earlier than anticipated. This clearance will facilitate earlier commercialization of the product. As a result, Medtronic expects a one-time charge of $157 million in Q4 FY2026, impacting non-GAAP EPS by $0.08 per share. Additionally, the IPO of 10% of MiniMed is expected to dilute earnings by $0.04 per share for Q4 FY2026. Consequently, Medtronic revised its non-GAAP EPS guidance for FY2026 to a range of $5.50 to $5.54, down from the previous guidance of $5.62 to $5.66.
- Filer
- Medtronic plc MDT · NYSE
- Filed
- Accession
- 0001613103-26-000005
- CIK
- 0001613103
- Signal
- High impactHealthcare
- Source
- Official filing on sec.gov ↗
Items reported
Reported Item
Market reaction
Close before filing
$87.17
Next session
+0.8%
Since filing
-2.0%
Latest close
$85.39
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About Medtronic plc
Medtronic plc is a leading global healthcare technology company that designs, manufactures, and sells innovative medical devices and therapies used in various medical procedures. The primary function of Medtronic is to improve healthcare outcomes by providing advanced therapeutic solutions. Its extensive product portfolio includes cardiac and vascular devices, diabetes-related products, minimally invasive therapies, and neurosurgical technologies. Medtronic plays a vital role in the medical device industry, catering to cardiovascular treatment, advanced diabetes management, spinal and musculoskeletal therapy, and more. Notably, the company is renowned for its pacemaker technology and is a pivotal player in cardiac care. The company's innovations significantly impact the healthcare sector by enhancing the quality of life for patients worldwide and improving the effectiveness of medical treatments. As a key player in the medical device market, Medtronic is instrumental in setting industry standards and advancing medical technology through continuous research and development. Founded in 1949 and headquartered in Dublin, Ireland, Medtronic's global presence underscores its substantial contribution to the healthcare industry across various continents.
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