Israeli medical devices developer Integrity Applications has secured CE Mark approval for its GlucoTrack DF-F, a non-invasive blood glucose monitoring device.
This glucose measuring equipment uses a patented combination of ultrasound, electromagnetic and thermal technologies to quickly obtain measurements of blood glucose levels through a small sensor that is clipped to the earlobe and linked to a smartphone-sized, handheld control and display unit, all without drawing blood.
Integrity Applications president and CEO Avner Gal said; "Receipt of the CE Mark positions Integrity Applications 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 of the device was based on clinical data collected utilising over 6,000 measurements during 2012 at the Soroka University Medical Center in Israel.
Findings of the clinical data showed a positive correlation between GlucoTrack DF-F readings and those obtained from conventional invasive devices.
According to the estimates of the World Health Organization, there are 347 million people suffering with diabetes worldwide as of March 2013, and deaths from diabetes are estimated to increase by over 50% in the next decade.
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.