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GALWAY - Medtronic plc (NYSE:MDT), a $114.8 billion market cap healthcare giant and prominent player in the medical devices industry, announced Monday it has received CE Mark approval to expand indications for its MiniMed 780G automated insulin delivery system in Europe to include individuals as young as 2 years old, pregnant women, and people with type 2 insulin-requiring diabetes. According to InvestingPro analysis, the company’s stock is currently trading near its 52-week high, reflecting strong market confidence in its growth strategy.
The expanded approval was based on clinical data including the LENNY trial published in The Lancet Diabetes & Endocrinology, which demonstrated safety and efficacy in children aged 2-6 years with type 1 diabetes. Trial participants using the system in auto mode achieved 0.6% lower HbA1C and 9.9% higher time in range compared to manual mode.
For pregnant women with type 1 diabetes, a European study showed participants using the MiniMed 780G system achieved an average Pregnancy Time in Range of 66.5%, with improved overnight glucose control and reduced hypoglycemia.
The system’s approval for type 2 diabetes was supported by a multi-center trial of 95 participants that showed a 0.7% reduction in HbA1C and increased time in range to 80%. Real-world data from over 26,000 type 2 diabetes users demonstrated glycemic control exceeding international consensus targets.
"As a parent, nothing is more important than giving my child the freedom to just be a kid - but managing type 1 diabetes made that feel nearly impossible," said Paul Schulz from Barcelona, whose son Marc lives with type 1 diabetes.
In the United States, Medtronic is working with the FDA on approval for type 2 diabetes use, while clinical trials for 2-6 year olds are ongoing.
The MiniMed 780G system automates insulin delivery every five minutes based on continuous glucose monitoring readings and can be set to a target glucose level of 100 mg/dl.
According to the company’s press release statement, the expanded indications reflect Medtronic’s commitment to improving access to automated insulin delivery technology for more diverse populations. InvestingPro research reveals the company maintains a strong financial health score of GOOD, with analysts projecting continued profitability. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, covering this and 1,400+ other top US stocks.
In other recent news, Medtronic has received a proposed National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS) for its renal denervation (RDN) therapy. This proposal includes coverage for patients with uncontrolled hypertension, aligning with Medtronic’s clinical trial parameters. The decision is seen as a significant step for Medtronic’s Symplicity Spyral device, which received FDA approval in November 2023. Analysts from firms like BofA Securities and JPMorgan have noted the potential market opportunity, with estimates suggesting the therapy could add $100-150 million in annual revenue growth for Medtronic. Despite the positive development, Goldman Sachs maintained a Sell rating, noting that revenue contribution may progress gradually. William Blair reiterated a Market Perform rating, observing that the company has been preparing for market entry by expanding its commercial organization and training physicians. The final decision on this coverage is expected by October 8, 2025, which could formalize reimbursement and drive broader market adoption. This development comes after 15 years of clinical trials and investments in RDN technology by Medtronic.
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