Insulet Announces FDA 510(k) Clearance of the Omnipod® 5 App for iPhone

Rhea-AI Summary

Insulet Corporation has received FDA clearance for the Omnipod 5 App for iPhone, making it the first company to offer a tubeless automated insulin delivery system with full control from a compatible Android and iOS smartphone.

Positive

• Insulet is the first company to offer a tubeless automated insulin delivery system with smartphone control.
• The Omnipod 5 App for iPhone will provide more options for users who prefer not to carry an extra device.
• The app offers additional capabilities and an intuitive design, including a custom foods feature.

Negative

• None.

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, today announced it has received FDA 510(k) clearance for the Omnipod 5 App for iPhone, making Insulet the first and only company to offer a tubeless automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone.

“Today, we celebrate this significant milestone in our ongoing effort to provide people with diabetes solutions that improve their lives and help them think less about diabetes,” said Eric Benjamin, Executive Vice President, Chief Product & Customer Experience Officer. “We are thrilled to add the iOS platform to our mobile app offerings and elevate Omnipod 5’s market-leading position in phone-controlled AID systems.”

Since its full commercial launch in August 2022 in the United States, the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) has included the option for smartphone control for customers using compatible Android devices. With today’s announcement, the Omnipod 5 Pod will soon be controllable from a compatible iPhone, providing even more options for users who prefer not to carry an extra device.

Designed with users in mind, the Omnipod 5 App for iPhone offers the same functionality as the Omnipod 5 App for Android, plus additional capabilities, and an intuitive design. Users will have access to a new custom foods feature with the ability to save carbohydrate data for favorite foods, snacks, or meals that are consumed frequently.

The Omnipod 5 App for iPhone will launch first with the Dexcom G6 Continuous Glucose Monitoring System integration, with a full market release in 2024. Users of the Omnipod 5 System can download the iPhone App free of charge once available.

People with type 1 diabetes who are interested in Omnipod 5 should contact their healthcare providers to learn how to get started on the system today. The Omnipod 5 App for iPhone will be a simple transition for those with compatible devices once available. Insulet will inform the diabetes community of the release timing closer to the date. To stay informed of Insulet’s progress with future innovation, visit Omnipod.com/innovation. More information is also available on the Omnipod website.

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s latest innovation, the Omnipod 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system, integrated with a continuous glucose monitor to manage blood sugar with no multiple daily injections and zero fingersticks. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit: insulet.com and omnipod.com.

Forward-Looking Statement:

This press release may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 24, 2023 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary materially from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

©2023 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231023890455/en/

Investor Relations:

Deborah R. Gordon

Vice President, Investor Relations

(978) 600-7717

dgordon@insulet.com

Media:

Angela Geryak Wiczek

Senior Director, Corporate Communications

(978) 932-0611

awiczek@insulet.com

Source: Insulet Corporation

FAQ

What is the significance of Insulet receiving FDA clearance for the Omnipod 5 App for iPhone?

Insulet is the first and only company to offer a tubeless automated insulin delivery system with full control from a compatible Android and iOS smartphone.

What additional features does the Omnipod 5 App for iPhone offer?

The app offers a custom foods feature with the ability to save carbohydrate data for favorite foods, snacks, or meals that are consumed frequently.

When will the Omnipod 5 App for iPhone be available?

Insulet will inform the diabetes community of the release timing closer to the date.

How can people with type 1 diabetes get started on the Omnipod 5 System?

People with type 1 diabetes who are interested in Omnipod 5 should contact their healthcare providers to learn how to get started on the system today.