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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.

“This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022,” said Eric Benjamin, Insulet EVP and COO. “These new features address the two most requested enhancements and reflect our relentless commitment to delivering meaningful innovation for those living with diabetes and the healthcare providers who support them. Every improvement we make is designed to strengthen clinical outcomes while making the Pod experience simpler, more personalized, and so seamless it disappears into everyday life.”

More about the enhancements to the Insulet Omnipod 5

Insulet said the new 100 mg/dL target glucose expands Omnipod 5’s customization range. It now features six settings between 100 mg/dL and 150 mg/dL in 10 mg/dL increments. The company said this flexibility allows healthcare providers to tailor insulin delivery more precisely. It supports individuals seeking tighter glucose management or aiming to meet specific glucose goals.

Additionally, the company said it directly impacts automated insulin delivery, improving the algorithm’s responsiveness. Real-world evidence previously demonstrated that lowering the glucose target often coincides with increased time in range.

Omnipod 5’s latest upgrades also help users stay in “Automated Mode” with fewer interruptions, even during prolonged high glucose events. Insulet said this helps deliver strong clinical results with increased flexibility and greater ease of use. It also means plus fewer interruptions to daily life.

Insulet plans to launch the updates to the algorithm in the first half of 2026.

“These enhancements to the Omnipod 5 algorithm are a meaningful step forward. As a clinician, it’s exciting to offer patients a system that not only supports strong clinical outcomes but also builds their confidence in managing diabetes daily. More target glucose options and fewer interruptions mean a better experience for people with diabetes and their families,” said Dr. Anita Swamy, pediatric endocrinologist and medical director of the Chicago Children’s Diabetes Center.

Read more about Insulet, its technology, and the rest of the diabetes tech industry in our free Diabetes Technology Special Report.

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: FDA, Insulet

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About Sean Whooley

Sean Whooley is an associate 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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