Aug 18,2020

NuvoAir respiratory platform receives Class Im medical device status

Sweden-based digital therapeutics respiratory company, NuvoAir, has been certified as a Class Im medical device. The NuvoAir Home platform includes Air Next, a certified bluetooth spirometer, a connected patient app and a healthcare portal. Patients can use the platform to self-monitor their respiratory health and share clinically relevant data with their care teams, who can view this data remotely via a healthcare portal.

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Sep 08,2020

Nerivio® Smartphone-Controlled Wearable for Acute Treatment of Migraine Granted CE Mark for Use in Europe

Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, today announced that it has been granted a CE mark for its Nerivio® device for acute treatment of migraine, a little more than a year after receiving FDA clearance in the United States. This milestone allows the award-winning wearable therapeutic device to be marketed in select countries in Europe, as part of the company's roll-out plan, starting in 2021

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Nov 16,2020

Voluntis Receives CE Mark for Oleena, Key Milestone to the Future Commercialization of Its Digital Therapeutics for Oncology

Voluntis, a leader in digital therapeutics, today announced that it has received the CE mark for Oleena. Oleena is Voluntis’ proprietary digital therapeutic that enables patients to self-manage symptoms across a wide range of cancer therapies, and also allows care teams to remotely monitor patients. Oleena is based on Voluntis’ Theraxium platform, and its patented algorithm engine, which also serves as the foundation for digital therapeutics the company co-develops with life science partners.

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Jul 25,2019

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

Global digital therapeutics innovator DarioHealth, 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.

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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.

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Oct 18,2017

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

This 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.

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Nov 05,2019

WaveForm Technologies Inc Awarded CE Mark Approval for Their CGM System

WaveForm Technologies Inc. a wholly owned subsidiary of AgaMatrix Holdings, LLC and developer of novel continuous glucose monitoring products, today announced it has received CE Mark approval for its Cascade Continuous Glucose Monitoring (CGM) system. Commercialization of the product for the European market is anticipated to begin in select countries.

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Mar 09,2021

Mahana Therapeutics Obtains CE Mark for Parallel™ in the UK

Mahana Therapeutics, an emerging leader in prescription digital therapeutics, announced today that it has obtained a CE mark for its flagship product Parallel™. Parallel is the first prescription-only digital therapeutic (PDT) intended to reduce the severity of irritable bowel syndrome (IBS) symptoms in adult patients.

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May 12,2021

Voluntis receives CE Mark for new version of Oleena with expanded clinical intelligence

Voluntis, a leader in digital therapeutics, today announced that it has received the CE mark for a new version of Oleena featuring expanded clinical intelligence. Oleena is Voluntis’ proprietary digital therapeutic that supports patients in the self-management of their symptoms in combination with a wide range of cancer treatments, while allowing healthcare teams to remotely monitor the progress of the disease. It is based on the Theraxium platform developed by Voluntis, which also serves as the foundation for the digital therapeutics the company is co-developing with pharmaceutical partners.

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May 14,2021

One Drop Receives CE Mark for AI-Powered Blood Glucose Forecasts

One Drop, a leader in precision health solutions for people living with chronic conditions, today announced it has achieved the Conformité Européenne (CE) Mark for its Blood Glucose Prediction Analysis Engine-1 to accurately forecast glucose levels up to eight hours in advance for people living with prediabetes, type 2 diabetes, and gestational diabetes.

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