FDA clears Insulet’s enhanced Omnipod 5 insulin delivery system

Published 12/04/2025, 07:10 AM
FDA clears Insulet’s enhanced Omnipod 5 insulin delivery system

ACTON, Mass. - Insulet Corporation (NASDAQ:PODD) has received FDA 510(k) clearance for significant enhancements to its Omnipod 5 Automated Insulin Delivery System, the company announced in a press release statement. The medical device maker, currently valued at $21.64 billion, has maintained strong financial health with an InvestingPro overall score of "GREAT" and impressive revenue growth of 27.11% over the last twelve months.

The approved updates include a new 100 mg/dL Target Glucose setting and algorithm improvements designed to help users remain in Automated Mode with fewer interruptions. The lower glucose target expands the customization range to six settings between 100-150 mg/dL in 10 mg/dL increments.

According to real-world evidence cited by the company, lowering the glucose target is associated with increased time in range without clinically meaningful changes in Time Below Range. The enhanced algorithm is also designed to maintain Automated Mode even during prolonged high glucose events.

"These new features address the two most requested enhancements and reflect our relentless commitment to delivering meaningful innovation for those living with diabetes," said Eric Benjamin, Insulet Executive Vice President and Chief Operating Officer.

Dr. Anita Swamy, Pediatric Endocrinologist and Medical Director of the Chicago Children’s Diabetes Center, noted that the enhancements offer "more target glucose options and fewer interruptions" for diabetes management.

The Omnipod 5 system is currently cleared for people aged 2 and older with type 1 diabetes and adults 18 and older with type 2 diabetes. Insulet expects to launch the updated algorithm in the United States during the first half of 2026. The company remains profitable with earnings per share of $3.50 and operates with a moderate debt level, maintaining a healthy current ratio of 2.87 that indicates strong liquidity.

The tubeless insulin delivery system allows for up to three days of non-stop insulin delivery without multiple daily injections or fingersticks, and can be controlled by a compatible personal smartphone in the U.S. Notably, InvestingPro data shows Insulet is slightly undervalued based on its Fair Value estimate, with 18 analysts recently revising their earnings upward for the upcoming period. Investors seeking deeper insights can access Insulet’s comprehensive Pro Research Report, one of 1,400+ detailed analyses available exclusively through InvestingPro.

In other recent news, Insulet Corporation has seen several updates from analyst firms following its Investor Day presentation. UBS has maintained its Buy rating and a price target of $400, emphasizing the company’s competitive advantages, including brand strength and manufacturing capabilities. Canaccord Genuity has raised its price target for Insulet to $432, up from $428, while also keeping a Buy rating. This adjustment reflects Insulet’s long-range plan and innovation roadmap for 2025-2028, which was unveiled during the Investor Day. Bernstein has reiterated an Outperform rating with a $410 price target, citing Insulet’s strong market position and growth potential. The firm highlighted Insulet’s strategy to increase its presence in the U.S. Type 1 diabetes market and develop the Type 2 diabetes market, along with international expansion. UBS also noted Insulet’s ambitious sales growth target of approximately 20% over the 2025-2028 period, which surpasses both UBS and Street estimates. Additionally, Insulet aims for an annual operating margin expansion of about 100 basis points. These developments underscore the company’s strategic focus on growth and innovation in the coming years.

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