Medtronic plc develops and manufactures therapeutic medical devices and healthcare technology for chronic diseases and procedural care. Its news commonly covers regulatory clearances and CE marks, product launches, clinical data, acquisitions, and financial results across cardiovascular, cardiac rhythm management, cranial and spinal technologies, surgical navigation, robotics, and ablation systems.
Recent company updates include the Stealth AXiS™ surgical system for planning, navigation, and robotics; the Affera™ mapping and ablation system with Sphere-9™ and Sphere-360™ catheters; the OmniaSecure™ defibrillation lead; and the completed CathWorks acquisition, including the FFRangio® System for coronary artery disease assessment.
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Medtronic plc (NYSE:MDT) has resolved a warning letter from the FDA regarding its Diabetes headquarters in Northridge, California, which was received in December 2021. The FDA's decision comes shortly after the agency approved the MiniMed™ 780G system, the first automated insulin delivery system with real-time meal detection technology. The new system adjusts glucose levels automatically every five minutes, addressing significant needs in diabetes management. Medtronic expresses gratitude for the collaborative efforts with the FDA, which enable the company to focus on delivering innovative solutions for diabetes patients. This resolution marks a crucial step for Medtronic's Diabetes division, ensuring adherence to quality standards and paving the way for future advancements.
Medtronic plc (NYSE: MDT) announced FDA approval for its MiniMed™ 780G system with Guardian™ 4 sensor, the first insulin pump featuring meal detection technology. This device delivers automatic adjustments to insulin every 5 minutes, addressing challenges faced by individuals with type 1 diabetes during mealtimes. It offers the lowest glucose target setting of any automated insulin pump, enhancing user experience with 94% of users expressing satisfaction. Clinical trials indicate users achieved a 75% Time in Range for blood sugar levels. Pre-orders will begin on May 15, 2023, and existing MiniMed™ 770G customers can upgrade at no cost.