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.
Medtronic highlights its partnership with Springfield Spring and Stamping, a certified minority-owned business, emphasizing the importance of supplier diversity. This collaboration is a crucial component of Springfield's growth, enabling it to invest in advanced manufacturing technologies. The partnership not only benefits Springfield's business but also contributes to creating well-paying jobs and strengthening the local community. Springfield Spring's owner, Norman Rodrigues, noted that Medtronic's support has been foundational for their company's success, fostering sustainable wealth and economic security for employees. This initiative reflects Medtronic's commitment to community impact and economic development through responsible sourcing.
Medtronic LABS is expanding its scope to address comprehensive community health needs rather than focusing solely on specific diseases. Acknowledging that over 5 billion people lack access to healthcare, the organization aims to enhance healthcare delivery across various conditions including hypertension, diabetes, mental health, and more.
With its technology platform SPICE, LABS has reached over 1 million patients and trained more than 6,500 health workers globally. The initiative is set to grow further with new partnerships, potentially amplifying its impact 10 times over the next few years.