GALWAY, Ireland - Medtronic plc (NYSE: MDT), a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $107.4 billion and annual revenue of $33.2 billion, has announced the submission of two 510(k) applications to the U.S. Food and Drug Administration (FDA) for a new interoperable insulin pump. According to InvestingPro analysis, the company maintains a robust gross profit margin of 65.6%, demonstrating strong operational efficiency. The submissions include an application for the MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).
The FDA clearance of these devices would facilitate system integration with a continuous glucose monitoring (CGM) sensor developed by Abbott. This move is part of a collaboration between the two companies announced in August, aiming to create an integrated system based on Abbott’s advanced CGM platform. InvestingPro data reveals that Medtronic maintains a strong financial health score of GOOD, suggesting it’s well-positioned to execute on strategic initiatives like this collaboration.
According to Medtronic’s EVP & president of Diabetes, Que Dallara, the company is working with urgency to bring enhanced CGM options to customers, emphasizing the significance of the collaboration with Abbott in providing innovative solutions and more choice.
The partnership entails Abbott supplying Medtronic with CGM sensors that will work exclusively with Medtronic’s smart dosing devices and software for both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.
Further details regarding the FDA clearance will be disclosed upon approval. Medtronic Diabetes is committed to advancing diabetes management technology, including next-generation sensors, intelligent dosing systems, and leveraging data science and AI. Based on InvestingPro’s Fair Value analysis, Medtronic appears slightly undervalued at current levels, with additional ProTips and comprehensive analysis available through InvestingPro’s detailed research reports, which cover over 1,400 US stocks including MDT.
This news is based on a press release statement and the information provided is subject to approval by the FDA. Medtronic cautions that forward-looking statements in the press release are not guarantees of future performance and actual results may differ due to various factors, including regulatory approvals. The company has not made any further commitments to update these statements beyond the date of the press release.
In other recent news, Medtronic has reported significant developments in various areas of its business. The company announced that its BrainSense™ Adaptive deep brain stimulation (aDBS) system has received FDA approval, marking a major advancement in personalized treatment for Parkinson’s disease. This innovative technology adjusts therapy in real-time based on individual brain activity and is expected to be available in the United States soon. In financial news, Medtronic’s fiscal third quarter for 2025 showed a 4.1% year-over-year organic revenue growth to $8.29 billion, although this was slightly below the consensus estimate. However, earnings per share of $1.39 surpassed expectations, leading Citi to upgrade Medtronic’s stock rating to Buy with a new price target of $104.
Additionally, Piper Sandler maintained a neutral stance on Medtronic, with a price target of $90, noting the company’s renal denervation (RDN) technology. Stifel also maintained a Hold rating on Medtronic with an $87 target, observing that Medtronic’s Transcatheter Aortic Valve Replacement (TAVR) technology continues to show non-inferiority to traditional surgery. Furthermore, Orchestra BioMed, in collaboration with Medtronic, received FDA Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, which is under assessment in a global study for patients with uncontrolled hypertension. These recent developments underscore Medtronic’s ongoing efforts to innovate and expand its medical technology offerings.
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