MDT News & Events

Medtronic announced U.S. FDA clearance of the Stealth AXiS surgical system for cranial and ear, nose, and throat procedures. Cleared for spine procedures in February, the Stealth AXiS surgical system unifies surgical planning, navigation, and robotics into a single intelligent system to support surgeons with greater precision and real-time insights during complex procedures. This clearance reinforces Medtronic's strategy to deliver connected technologies that support surgeons across multiple specialties on a single platform.

The company states: "On March 18, 2026, MiniMed Group, a consolidated subsidiary of Medtronic plc announced that the FDA has cleared the MiniMed Flex, a next-generation discreet, smartphone-controlled insulin pump. The clearance of the MiniMed Flex by the FDA was several months earlier than anticipated, and will facilitate the earlier commercialization of this key MiniMed product. The research and development of the MiniMed Flex was funded in part by affiliates of Blackstone Life Sciences Advisors L.L.C. (Blackstone). Under the research and development agreement between MiniMed and Blackstone, in exchange for funding the development of the MiniMed Flex, during the first two years following regulatory approval in the U.S. and commercial launch of the MiniMed Flex, Blackstone will earn the greater of: (i) mid-to-high single digit royalty percentage of applicable net sales, and (ii) specified minimum payments. MiniMed is expected to recognize a one-time charge of $157 million in the fourth quarter of fiscal year 2026 related to the series of future payments due to Blackstone, which is expected to result in an $0.08 per share impact to Medtronic's consolidated results for the fourth quarter of fiscal year 2026, based on Medtronic's 90% ownership interest in MiniMed. These arrangements are not expected to have an impact on Medtronic's results for fiscal year 2027. In addition, as previously disclosed during the Company's Q3 earnings call, the timing of the March 9, 2026 closing of the initial public offering (IPO) of 10% of MiniMed is expected to result in dilution of approximately $0.02 per share to Medtronic shareholders for each month of the quarter following the IPO. This will result in an aggregate dilutive impact of $0.04 per share during the fourth quarter of fiscal year 2026, which ends on April 24, 2026. As a result of the foregoing factors related to MiniMed that are expected to have an impact in the fourth quarter of fiscal year 2026, on March 24, 2026, Medtronic announced that it now expects non-GAAP earnings per share (EPS) for fiscal year 2026 to be in the range of $5.50 to $5.54, a revision from the Q3 earnings call EPS guidance of $5.62 to $5.66. The Company's guidance for fiscal year 2027 of high single-digit EPS growth remains unchanged, and is based upon the prior guidance from the Q3 earnings call, prior to the MiniMed-related updates announced here."

Medtronic (MDT) announced that it has entered into a distribution agreement with Merit Medical Systems (MMSI), to offer FDA-cleared ViaVerte, a minimally invasive and implant free basivertebral nerve ablation system. It is the first and only BVNA system with a physician-controlled steerable mechanism for precise basivertebral nerve targeting for treating chronic vertebrogenic lower back pain. This agreement continues Medtronic's momentum in executing on strategic deals that strengthen the company's leadership within its core franchises and expands an ongoing relationship between Medtronic and Merit.

Medtronic received U.S. FDA approval for an expanded indication for the OmniaSecure defibrillation lead. Now approved for placement in the left bundle branch area, the lead can be used for conduction system pacing, which closely mimics the heart's natural physiology. Additionally, patients in need of cardiac resynchronization may benefit from left bundle branch optimized cardiac resynchronization therapy, a novel therapy that combines CSP with left-ventricular pacing to further improve patient outcomes.