Artrya secures UK, EU approvals for Salix
Within a week, ASX-listed medtech company Artrya received both regulatory approvals from the European Union and the United Kingdom for its Salix Coronary Anatomy product.
The AI-powered software identifies and analyses arterial plaque to diagnose coronary artery disease.
The recent certifications allow Artrya to market Salix in 28 EU member countries and...
New EU guidance on classification of medical devices
New guidance on the classification of medical devices in the European Union (EU) has been published by the Medical Device Coordination Group (MDCG). This group is composed of representatives of all member states and chaired by a representative of the European Commission.
The document details how to classify medical devices, provides rules to...
Israeli medical startup, NanoVation, has been awarded a €2.5 million grant as part of the European Union’s Horizon 2020 EIC Accelerator program.
The funding will support the startup in developing SenseGuard, a new respiratory monitoring device, based on its proprietary nano-sensor technology.
WHY IT MATTERS
SenseGuard is a wireless wearable medical device for continuous monitoring of patients'...
The European Commission has formed a working group that will create guidelines to evaluate the accuracy and reliability of health app data. The group’s first meeting will be in March.
This initiative, the European Commission explained, is a follow up to a consultation announced in April 2014 that asked digital health companies and others for help in identifying ways to encourage and regulate...
This week the European Commission announced a consultation -- similar to a public notice from the FDA here in the US -- that asks digital health companies and others for help in identifying ways to encourage and regulate mobile health, which the Commission defines as "ways to enhance the health and wellbeing of Europeans with the use of mobile devices, such as mobile phones, tablets, patient...
Researchers at a university in Greece are coordinating a European Union funded project, called Splendid, that leverages sensors to record the eating habits and activity levels of children and young adults to nudge them into making healthier decisions. The study is aimed at curbing the obesity epidemic and initially includes 200 high school aged students in Sweden. Another group in Netherlands...
New York City-based Philosys recently announced that it had received a European CE Mark for its Gmate Smart glucose meter, which connects to the iPhone and iPad via the devices' headphone jacks. Philosys noted that the CE Mark approval was a year in the making and so it aims to bring the device to market in Europe by the end of this year.
As Medgadget points out, since the device uses the Apple...
