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Home » Insulet wins FDA clearance for Omnipod 5 algorithm enhancements

Insulet wins FDA clearance for Omnipod 5 algorithm enhancements

December 4, 2025 By Sean Whooley

Insulet Omnipod 5 worn on the back of an arm
The Omnipod 5 hybrid closed-loop insulin delivery system worn on the back of an arm. [Image courtesy of Insulet]
Insulet (Nasdaq: PODD) announced today that it received FDA 510(k) clearance for new enhancements to its Omnipod 5 system.

The Acton, Massachusetts–based company said the updates to its tubeless, wearable automated insulin delivery patch pump’s algorithm include a new benchmark in tubeless diabetes technology with a lower, 100 mg/dL target glucose option. It also delivers a more seamless automated experience.

Omnipod 5 is the first FDA-cleared tubeless automated insulin delivery system available on the market. It communicates with a CGM to proactively correct for glucose highs every five minutes and protect against lows with insulin dosing.

Insulet plans to continue enhancing the system and looking toward next-generation technologies. CEO Ashley McEvoy outlined some of the planned improvements in a recent interview with Drug Delivery Business News, while she and other Insulet leaders expanded on those plans during the company’s recent Investor Day event.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: 510(k), Diabetes, Drug Pumps, Drug-Device Combinations, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT Tagged With: FDA, Insulet

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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