Insulet Announces CE Mark Approval of Omnipod 5 Integration with Abbott FreeStyle Libre 2 Plus Sensor

Omnipod 5

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.

Patrick Crannell, Senior Vice President and International General Manager of Insulet

“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. 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.”

Tubeless Hybrid Closed Loop System

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.

Availability

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.

SourceInsulet

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”
Exit mobile version