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    FDA Clearance Of Lower-Target Omnipod 5 Upgrade Could Be A Game Changer For Insulet (PODD)

    Simply Wall St·12/05/2025 15:24:07
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    • Insulet Corporation recently received FDA 510(k) clearance for major enhancements to its Omnipod 5 Automated Insulin Delivery System, including a new 100 mg/dL target glucose option and a more seamless automated mode expected to roll out in the US in the first half of 2026.
    • This upgrade meaningfully extends personalization in tubeless insulin delivery, giving clinicians more fine-tuned control over glucose targets while helping users stay in automated mode with fewer disruptions to everyday life.
    • Next, we’ll explore how the lower 100 mg/dL glucose target and enhanced automation could influence Insulet’s broader investment narrative.

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    Insulet Investment Narrative Recap

    To own Insulet, you need to believe Omnipod can remain a leading, expanding diabetes platform despite intense innovation and pricing pressure. The new Omnipod 5 FDA clearance supports that thesis by tightening automation and personalization, but its impact on near term performance looks incremental compared with the broader questions around competition, reimbursement, and execution on global expansion.

    The earlier launch of Omnipod 5 in key European markets in January 2025 ties directly into this latest FDA clearance, reinforcing Insulet’s push to scale a single core platform across regions and indications. Together, these updates matter most if they help the company justify premium pricing while sustaining adoption in the face of rapid advances from larger medtech and tech rivals.

    However, investors should also be aware that rapid diabetes technology innovation could still...

    Read the full narrative on Insulet (it's free!)

    Insulet's narrative projects $3.9 billion revenue and $542.3 million earnings by 2028.

    Uncover how Insulet's forecasts yield a $378.21 fair value, a 20% upside to its current price.

    Exploring Other Perspectives

    PODD Community Fair Values as at Dec 2025
    PODD Community Fair Values as at Dec 2025

    Three fair value estimates from the Simply Wall St Community span roughly US$297 to US$661,388 per share, showing just how far apart individual views can be. Against that backdrop, Omnipod 5’s ongoing product upgrades highlight how much future performance hinges on Insulet defending its single core platform against fast moving competitors.

    Explore 3 other fair value estimates on Insulet - why the stock might be worth 6% less than the current price!

    Build Your Own Insulet Narrative

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    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.