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PODD Stock Benefits From FDA Approval of Omnipod 5's Enhancements
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Key Takeaways
PODD secured FDA clearance for Omnipod 5 enhancements, including a 100 mg/dL Target Glucose option.
PODD's updated algorithm aims to improve automated insulin delivery and reduce interruptions for users.
Insulet shares gained 2.7% after the news, supported by ongoing expansion of the Omnipod 5 platform.
Insulet Corporation (PODD - Free Report) recently received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System. These updates to the Omnipod 5 algorithm set a new benchmark in tubeless diabetes technology by offering a lower 100 mg/dL Target Glucose option and a more seamless automated experience.
The updates to the Omnipod 5 algorithm are anticipated to be launched in the United States in the first half of 2026.
PODD Stock’s Likely Trend Following the News
Following the announcement, PODD’s shares climbed 2.7% last Thursday. The company’s robust innovation efforts and ongoing expansion of the Omnipod 5 platform are solidifying its market leadership. We expect the market sentiment toward PODD stock to remain positive surrounding this development.
Insulet has a market capitalization of $21.42 billion at present. Going by the Zacks Consensus Estimate, the company’s earnings are likely to increase 50.9% in 2025 on a 30.0% improvement in revenues. In the trailing four quarters, it delivered an average earnings beat of 17.8%.
About PODD’s Omnipod 5
Omnipod 5 is the first and only FDA-cleared tubeless, waterproof AID system indicated for individuals with type 1 and type 2 diabetes. The system simplifies diabetes management and has shown an improvement in results by removing the need for multiple daily injections therapy, along with automatically adjusting insulin delivery every five minutes using its advanced SmartAdjust technology. It has demonstrated strong clinical results, including lower A1c and improved time in range, while maintaining low time in hypoglycemia.
Significance of the Latest FDA Clearance
The new 100 mg/dL Target Glucose expands Omnipod 5’s customization range to six settings in the range of 100-150 mg/dL in 10 mg/dL increments. This flexibility allows healthcare providers to tailor insulin delivery more precisely, supporting individuals seeking tighter glucose management or those striving to meet specific glucose goals. It also directly impacts automated insulin delivery and improves the algorithm’s responsiveness. Real world evidence has shown that lowering the glucose target is associated with increased time in range, with no clinically meaningful change in Time Below Range (TBR).
In addition, the upgraded Omnipod 5 algorithm helps users stay in Automated Mode with fewer interruptions, even during prolonged high glucose events. These advancements are designed to deliver strong clinical results with increased flexibility and greater ease of use, with fewer interruptions to daily life.
Image Source: Zacks Investment Research
Industry Prospects Favor PODD
Per a report by Towards Healthcare, the global insulin delivery system market size was calculated at $17.77 billion in 2024 and is projected to reach $38.09 billion by 2034, growing at a compound annual rate of 7.92% between 2024 and 2034. The increasing number of diabetic patients and technological advancements like automation, AI and machine learning are expected to support growth of the market.
Another Development by Insulet
Insulet’s Omnipod 5 App for iPhone has been compatible with the Dexcom G7 Continuous Glucose Monitoring (CGM) System. With this latest integration, the Omnipod 5 AID system combines the benefits of tubeless AID and Dexcom’s latest diabetes management technology, all conveniently controlled from an iPhone.
PODD Stock’s Price Performance
In the past year, Insulet’s shares have gained 14.8% compared to the industry’s decline of 1.1%.
Estimates for BrightSpring Health Services’ 2025 EPS have increased 5.7% in the past 30 days. Shares of the company have surged 92.3% in the past year compared with the industry’s 1.1% growth. BTSG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 45.1%. In the last reported quarter, it delivered an earnings surprise of 11.1%.
Illumina shares have lost 9.4% in the past year. Estimates for the company’s 2025 EPS have increased 0.9% to $4.71 in the past 30 days. ILMN’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, delivering an average surprise of 6.7%. In the last reported quarter, it posted an earnings surprise of 15.5%.
Omnicell shares have dropped 13.9% in the past year. Estimates for the company’s 2025 EPS have increased 8.3% to $1.70 in the past 30 days. OMCL’s earnings topped estimates in each of the trailing four quarters, delivering an average surprise of 38.7%. In the last reported quarter, it posted an earnings surprise of 41.7%.
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PODD Stock Benefits From FDA Approval of Omnipod 5's Enhancements
Key Takeaways
Insulet Corporation (PODD - Free Report) recently received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System. These updates to the Omnipod 5 algorithm set a new benchmark in tubeless diabetes technology by offering a lower 100 mg/dL Target Glucose option and a more seamless automated experience.
The updates to the Omnipod 5 algorithm are anticipated to be launched in the United States in the first half of 2026.
PODD Stock’s Likely Trend Following the News
Following the announcement, PODD’s shares climbed 2.7% last Thursday. The company’s robust innovation efforts and ongoing expansion of the Omnipod 5 platform are solidifying its market leadership. We expect the market sentiment toward PODD stock to remain positive surrounding this development.
Insulet has a market capitalization of $21.42 billion at present. Going by the Zacks Consensus Estimate, the company’s earnings are likely to increase 50.9% in 2025 on a 30.0% improvement in revenues. In the trailing four quarters, it delivered an average earnings beat of 17.8%.
About PODD’s Omnipod 5
Omnipod 5 is the first and only FDA-cleared tubeless, waterproof AID system indicated for individuals with type 1 and type 2 diabetes. The system simplifies diabetes management and has shown an improvement in results by removing the need for multiple daily injections therapy, along with automatically adjusting insulin delivery every five minutes using its advanced SmartAdjust technology. It has demonstrated strong clinical results, including lower A1c and improved time in range, while maintaining low time in hypoglycemia.
Significance of the Latest FDA Clearance
The new 100 mg/dL Target Glucose expands Omnipod 5’s customization range to six settings in the range of 100-150 mg/dL in 10 mg/dL increments. This flexibility allows healthcare providers to tailor insulin delivery more precisely, supporting individuals seeking tighter glucose management or those striving to meet specific glucose goals. It also directly impacts automated insulin delivery and improves the algorithm’s responsiveness. Real world evidence has shown that lowering the glucose target is associated with increased time in range, with no clinically meaningful change in Time Below Range (TBR).
In addition, the upgraded Omnipod 5 algorithm helps users stay in Automated Mode with fewer interruptions, even during prolonged high glucose events. These advancements are designed to deliver strong clinical results with increased flexibility and greater ease of use, with fewer interruptions to daily life.
Image Source: Zacks Investment Research
Industry Prospects Favor PODD
Per a report by Towards Healthcare, the global insulin delivery system market size was calculated at $17.77 billion in 2024 and is projected to reach $38.09 billion by 2034, growing at a compound annual rate of 7.92% between 2024 and 2034. The increasing number of diabetic patients and technological advancements like automation, AI and machine learning are expected to support growth of the market.
Another Development by Insulet
Insulet’s Omnipod 5 App for iPhone has been compatible with the Dexcom G7 Continuous Glucose Monitoring (CGM) System. With this latest integration, the Omnipod 5 AID system combines the benefits of tubeless AID and Dexcom’s latest diabetes management technology, all conveniently controlled from an iPhone.
PODD Stock’s Price Performance
In the past year, Insulet’s shares have gained 14.8% compared to the industry’s decline of 1.1%.
PODD’s Zacks Rank & Other Key Picks
Insulet currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are BrightSpring Health Services (BTSG - Free Report) , Illumina (ILMN - Free Report) and Omnicell (OMCL - Free Report) . While BrightSpring and Illumina sport a Zacks Rank #1 (Strong Buy) each, Omnicell carries a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for BrightSpring Health Services’ 2025 EPS have increased 5.7% in the past 30 days. Shares of the company have surged 92.3% in the past year compared with the industry’s 1.1% growth. BTSG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 45.1%. In the last reported quarter, it delivered an earnings surprise of 11.1%.
Illumina shares have lost 9.4% in the past year. Estimates for the company’s 2025 EPS have increased 0.9% to $4.71 in the past 30 days. ILMN’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, delivering an average surprise of 6.7%. In the last reported quarter, it posted an earnings surprise of 15.5%.
Omnicell shares have dropped 13.9% in the past year. Estimates for the company’s 2025 EPS have increased 8.3% to $1.70 in the past 30 days. OMCL’s earnings topped estimates in each of the trailing four quarters, delivering an average surprise of 38.7%. In the last reported quarter, it posted an earnings surprise of 41.7%.