Insulet Announces FDA 510(k) Clearance of the Omnipod® 5 App for iPhone
23 Ottobre 2023 - 12:00PM
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
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