Jul 24,2018

Companion Medical Receives CE Mark

Diabetes care company Companion Medical has just landed a CE mark for its InPen, a smart insulin pen. The connected device has already been FDA-cleared but this latest announcement means that it will be able to go on the EU market.

REGULATORY CE MARK

#insulin pen

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Sep 19,2018

The Actiste companion applications and The Benefit Loop are now CE certified.

The mobile applications and digital infrastructure of Brighter's award-winning service for insulin treated diabetics – Actiste® Diabetes Management as a Service – are now CE certified. The applications are offered exclusively to Actiste subscribers. Through The Benefit Loop, Actiste connects all relevant parties in the care chain; the patient receives support and guidance, relatives can monitor and the caregivers can adapt and improve.

REGULATORY CE MARK

#mobile app

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Nov 07,2018

Diabeloop obtains CE marking and launches new round of funding

Diabeloop announced today it has received the CE marking for the DBLG1™, its innovative technological solution to radically improve quality of life for T1D patients through better blood sugar management. This news represents an important step towards the commercial release of the product.

REGULATORY CE MARK
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Sep 12,2017

Senseonics Announces CE Mark Approval for Eversense® XL CGM System

Senseonics Holdings, Inc. (NYSE-MKT-SENS) today announced it has received CE Mark approval for the Eversense® XL Continuous Glucose Monitoring (CGM) System. The Eversense XL System includes an extended life implanted glucose sensor lasting up to 180 days, a removable discreet smart transmitter, and a mobile app for display of real-time glucose readings.

REGULATORY CE MARK
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Oct 18,2017

DarioHealth Gains CE Mark for iPhone 7 and iPhone 8 Smart Glucose Meter

DarioHealth Corp. (NASDAQ: DRIO), a leading global digital health company with mobile health and big data solutions, announced today that it received the CE Mark for its Lightning®-enabled version of the acclaimed Dario™ Blood Glucose Monitoring System. The news ensures that consumers, beginning in the UK market, will be able to receive the same quality user experience with DarioHealth on the latest Apple devices, including the brand-new iPhone 8.

REGULATORY CE MARK

#bgm

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Mar 15,2016

Nemaura Medical Announces receipt of notification of CE Approval for its sugarBEAT® Continuous Glucose Monitoring System

Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive wireless continuous glucose monitoring (“CGM”) system known as sugarBEAT®, announced today that it has received notification of CE Approval for its sugarBEAT® system from its European Notified Body.

REGULATORY CE MARK

#cgm

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May 11,2016

Senseonics receives CE Mark for implantable continuous glucose monitoring system

Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, has received a CE Mark for its Eversense Continuous Glucose Monitoring (CGM) System.

REGULATORY CE MARK

#cgm

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May 17,2016

ASCENSIA DIABETES CARE RECEIVES CE MARK FOR THE STATE-OF-THE-ART CONTOUR™ NEXT ONE AND CONTOUR™ PLUS ONE BLOOD GLUCOSE MONITORING SYSTEMS

Today, Ascensia Diabetes Care announced that it has received CE Mark (Conformité Européenne) for the new CONTOUR™ NEXT ONE and CONTOUR™ PLUS ONE blood glucose monitoring systems, the next exciting development in the evolution of self-monitoring of blood glucose for people with diabetes.

REGULATORY CE MARK

#bgm

#mobile app

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Jul 19,2016

Medtronic gets CE Mark for smartphone-connected CGM

Medtronic has received a CE Mark for its Guardian Connect mobile continuous glucose monitor (CGM) and app. The company will begin selling the system in select countries in Europe, Asia, and Latin America in Q2 2017 and expects to receive FDA clearance to launch the device in the US around that same time.

REGULATORY CE MARK

#cgm

#mobile app

#insulin pump

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Dec 19,2016

POCTech achieved the first CE certificate of CGMS

Continuous Glucose Monitoring system of POCTech Corporation received first CE certificate, it is a key point for this product to get into European medical market.

REGULATORY CE MARK

#cgm

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