Medtronic gains FDA nod for Simplera™ CGM, partners with Abbott globally

Medtronic plc, a prominent figure in healthcare technology, has received U.S. FDA approval for its new Simplera™ continuous glucose monitor (CGM). This innovative device is Medtronic's first disposable, all-in-one CGM, designed to be significantly smaller than its predecessors. The compact design of the Simplera™ CGM aims to improve user comfort and convenience by simplifying the insertion process and eliminating the need for additional tape to secure it in place.

The Simplera™ CGM is part of Medtronic’s new platform, which includes the Simplera Sync™ sensor. The CGM can be utilized as part of a Smart MDI (multiple daily injections) system when paired with the InPen™ smart insulin pen. The Simplera Sync™ sensor is also designed to integrate seamlessly with the MiniMed™ 780G system. Both the Simplera™ CGM and Simplera Sync™ sensor have been CE marked in Europe and launched earlier this year, receiving positive feedback for their ease of use and user satisfaction.

The recent FDA approval sets the stage for further developments, including the submission of an updated app for the InPen™ smart insulin pen which will eventually integrate with the Simplera™ CGM. Medtronic plans to commence a limited market release in the U.S. once FDA clearance is obtained, starting with existing CGM and InPen™ customers. The Simplera Sync™ sensor is still under review by the FDA and is not yet approved for commercial use in the U.S. Additional global regulatory submissions and approvals are currently in progress.

In a significant strategic move, Medtronic announced a global partnership with Abbott to enhance CGM options for diabetes patients. This collaboration will see the development of an integrated CGM based on Abbott's advanced CGM technology, which will be exclusively compatible with Medtronic's smart dosing devices and software across both automated insulin delivery and Smart MDI systems. Medtronic will exclusively market these systems, including the Abbott-based CGM.

Financially, this original equipment manufacturer (OEM) agreement is expected to boost Diabetes revenue for Medtronic while maintaining a neutral gross margin for the Diabetes segment. Specific financial details and the timeline for commercial availability have not been disclosed.

Que Dallara, executive vice president and president of Medtronic Diabetes, highlighted the benefits of the partnership with Abbott, expressing enthusiasm about offering a wider range of CGM options to enhance the diabetes management experience for users. The partnership aims to deliver superior outcomes and increased access to advanced insulin delivery systems.

Jared Watkin, executive vice president of Abbott's diabetes care business, echoed these sentiments, emphasizing that integrating Abbott’s CGM technology with Medtronic’s advanced insulin delivery systems will simplify diabetes management and improve the quality of life for patients.

Medtronic remains committed to advancing its offerings for individuals requiring intensive insulin delivery. The company's pipeline includes next-generation durable and patch automated insulin delivery systems, smart pens, CGMs, algorithms, software, and services. Medtronic also plans to expand the therapy indications for its products.

Medtronic Diabetes continues its mission to alleviate the burden of diabetes through advanced technology and dedicated support. With over 40 years of pioneering innovations in diabetes management, the company is focused on future advancements in CGMs, intelligent dosing systems, and leveraging data science and AI to enhance the patient experience. Medtronic’s commitment to improving diabetes management is underpinned by its broader mission to alleviate pain, restore health, and extend life, driven by its global team and diverse technological expertise.

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