Insulet Announces CE Mark Approval of Omnipod® 5 Integration with Abbott FreeStyle Libre 2 Plus Sensor
07 Febrero 2024 - 5:00AM
Business Wire
- Omnipod 5 is the world’s first tubeless automated insulin
delivery system to achieve CE mark approval with multiple
continuous glucose monitoring (CGM) sensor brands.
- Latest Omnipod 5 integration is expected to be available in
the United Kingdom and Netherlands in the first half of 2024, with
additional markets to follow.
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 CE mark approval
under the European Medical Device Regulation for the added
compatibility of the Abbott FreeStyle Libre 2 Plus sensor with
Insulet’s Omnipod 5 Automated Insulin Delivery System for
individuals aged two years and older with type 1 diabetes.
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The Omnipod 5 Automated Insulin Delivery
System with the Abbott FreeStyle Libre 2 Plus CGM sensor (Photo:
Business Wire)
“The addition of the Abbott FreeStyle Libre 2 Plus sensor to our
CGM compatibility expands accessibility of Omnipod 5, which has
been a priority for Insulet since the system launched in 2022,”
said Patrick Crannell, Senior Vice President and International
General Manager of Insulet. “We are excited to have achieved this
key milestone, which allows us to bring Omnipod 5 and choice of CGM
to more people with diabetes.”
Omnipod 5 is the first and only tubeless hybrid closed loop
system (also known as automated insulin delivery) that is approved
for CE marking and integrated with two CGM sensor brands, Abbott
FreeStyle Libre and Dexcom. The Omnipod 5 System consists of the
tubeless Pod enhanced with SmartAdjust™ Technology and the Omnipod
5 Controller with its integrated Smartbolus Calculator.
The Pod’s SmartAdjust technology receives a CGM value and trend
and predicts where glucose will be 60 minutes into the future. The
System corrects every five minutes based on the user’s desired and
customized glucose target.
Insulet expects Omnipod 5 integration with the Abbott FreeStyle
Libre 2 Plus sensor to be available first in the United Kingdom and
Netherlands in a phased launch in the first half of 2024, with
additional markets to follow.
To learn more about Omnipod 5, visit 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
flagship 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, zero fingersticks, and can be fully
controlled by a compatible personal smartphone or the Omnipod 5
Controller. 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.
©2024 Insulet Corporation. Omnipod and SmartAdjust are
trademarks or registered trademarks of Insulet Corporation in the
United States of America and other various jurisdictions. All
rights reserved. The sensor housing, FreeStyle, Libre, and related
brand marks are marks of Abbott and used with permission. Dexcom is
a registered trademark of Dexcom, Inc. and used with permission.
All other trademarks are the property of their respective
owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20240207666366/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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