Integrity Applications, an Israel-based medical device company, has received CE Mark approval for its GlucoTrack DF-F non-invasive device.
The GlucoTrack DF-F is a glucose measuring device that uses a patented combination of ultrasound, electromagnetic, and thermal technologies to receive blood glucose measurements in less time through a small sensor clipped to the earlobe, connected to a smartphone-size, handheld control and display unit, all without drawing blood.
Integrity Applications CEO Avner Gal said that the receipt of the CE Mark positions the company to accelerate its discussions with distributors in the EU and other countries and, eventually, to offer to diabetics in the EU a solution that allows them to test themselves more frequently without the pain of needle pricks, and the inconvenience and cost of test strips in the day-to-day management of their disease.
"We know that taking frequent blood glucose measurements improves patient care by facilitating glycemic control, and we believe that non-invasive testing will encourage more frequent measurements by diabetics," Gal added.
The approval enables the company to market and sell the device in European Union (EU) member countries and those countries that have an MDD mutual recognition agreement with the EU.
The clearance of the device was given based on clinical data collected utilising over 6,000 measurements during 2012 at the Soroka University Medical Center in Israel.