Sep 20,2022

Insulet Announces CE Mark Approval for Omnipod® 5 Automated Insulin Delivery System

Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received CE marking under the European Medical Device Regulation for its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes.

REGULATORY CE MARK

#cgm

View Analyst & Ambassador Comments
Go to original news
Sep 20,2022

Insulet wins CE Mark for Omnipod 5 for children 2 and up

Insulet can now market Omnipod 5 in Europe for individuals 2 years and older with type 1 diabetes. Acton, Massachusetts–based Insulet said it represents the first CE-marked tubeless hybrid closed loop system

REGULATORY CE MARK

#cgm

View Analyst & Ambassador Comments
Go to original news
Mar 06,2019

Voluntis receives CE Mark to add NPH/isophane to Insulia

Today, Voluntis announced that it had obtained the CE mark for the new version of Insulia that integrates intermediate-acting neutral protamine Hagedorn (NPH) insulin, also known as isophane insulin. Insulia is the first digital therapeutic with regulatory clearance to provide automated titration recommendations for all types of basal insulin, including NPH insulin as well as all first and second generation long-acting basal insulin analogs.

REGULATORY CE MARK

#dtx

View Analyst & Ambassador Comments
Go to original news
Jul 25,2019

DarioHealth USB Type C Connector for the European Android Market Is CE Marked

Global digital therapeutics innovator DarioHealth Corp. (Nasdaq: DRIO), today announced that its CE certificate covers a USB-C connector enabled version of the acclaimed Dario™ Blood Glucose Monitoring System. The USB-C connector is used to transfer power and communication signals between Android smart mobile devices and the Dario meter, and ensures that consumers, beginning with the Europe market region, will receive the same quality user experience with DarioHealth on the latest Android smart phone devices.

REGULATORY CE MARK

#bgm

View Analyst & Ambassador Comments
Go to original news
Sep 03,2019

Actiste – world’s first unified IoT diabetes care device – has received market approval (CE mark).

Actiste®, the world’s first unified diabetes care device with eSIM technology for monitoring and treating insulin-dependent diabetes, has received not only one, but two, EC certificates (CE marks) from TÜV Rheinland (Notified Body).

REGULATORY CE MARK

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Dec 10,2019

Roche receives CE Mark for its Accu-Chek SugarView app

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has obtained the CE Mark for its Accu-Chek SugarView app. This paves the way for the launch of the innovative diabetes management solution in Europe and further countries around the world requiring the CE Mark. Now officially classified as in-vitro diagnostics (IVD) software, the app will be made widely accessible by Roche first for certain smartphone models via the Google Play Store, thus enabling broader access to therapy relevant information for non-insulin dependent people with type 2 diabetes or pre-diabetes.

REGULATORY CE MARK

#mobile app

View Analyst & Ambassador Comments
Go to original news
Feb 15,2018

DreaMed Diabetes has received a CE Mark for its Type 1-focused clinical decision support (CDS) platform

DreaMed Diabetes has received a CE Mark for its Type 1-focused clinical decision support (CDS) platform, Advisor Pro. The tool’s algorithms process data from a number of connected diabetes management devices to provide a personalized insulin dosing treatment plan. The software achieved similar glycemic control when compared to medical experts during pilot studies, according to DreaMed, and a multi-center trial run with Glooko (which announced a similar approval yesterday) is currently underway.

REGULATORY CE MARK
View Analyst & Ambassador Comments
Go to original news
Feb 15,2018

DreaMed Diabetes Receives CE Mark for Platform for the Management of Type 1 Diabetes

DreaMed Diabetes, developer of diabetes management solutions, announced today that it received CE Mark for the Advisor Pro decision-support platform for assisting healthcare professionals in the management of Type 1 diabetes.

REGULATORY CE MARK
View Analyst & Ambassador Comments
Go to original news
Apr 30,2018

Tandem Diabetes Care Receives CE Mark for t:slim X2 Insulin Pump

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced receipt of CE mark approval for the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration. The Company plans to begin commercial sales of the pump in select international markets beginning in the second half of 2018. The Company has been commercializing its touchscreen insulin pumps in the United States since 2012, and received U.S. Food and Drug Administration (FDA) approval of the t:slim X2™ Insulin Pump with Dexcom G5 Mobile CGM integration in August 2017.

REGULATORY CE MARK

#cgm

View Analyst & Ambassador Comments
Go to original news
Jun 25,2018

Medtronic Receives CE Mark for MiniMed 670G Hybrid Closed Loop System

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for the MiniMed(TM) 670G hybrid closed loop system - the first and only system to automate and personalize the delivery of basal insulin 24 hours a day1. The system is CE Mark approved for the treatment of people with type 1 diabetes 7 years of age and older with ongoing studies to expand the indication to additional patient populations.

REGULATORY CE MARK

#closed loop

View Analyst & Ambassador Comments
Go to original news
Subscribe to CE MARK