US-based Seventh Sense Biosystems has obtained CE Mark approval for its Touch Activated Phlebotomy (TAP) blood collection and testing system.
Seventh Sense Biosystems' TAP painless blood collection platform allows the collection of capillary blood through microfluidic extraction process and stabilizes the blood with anticoagulant if required.
The TAP system features a micro-needle which allows the penetration into the uppermost layers of skin.
The device has a visual indicator to confirm that the blood collection is complete.
Seventh Sense Biosystems president and CEO Howard Weisman noted this first regulatory approval is a significant milestone in the company's goal of expanding the reach of blood-based point-of-care diagnostics to a majority of patients, regardless of geography or setting.
"When fully commercialized, the TAP platform will incorporate additional capabilities for sample separation as well as dried blood spot and on-board diagnostic capabilities.
"We've surveyed patients and their physicians around the world and found a significant need for near painless, simple-to-use, and reliable blood collection and diagnostic devices that has so far been unmet," Weisman added.
Seventh Sense Biosystems intends to increase manufacturing capability in 2014 and continue the development of follow-on products for patients and clinicians in the US, Europe and Asia-Pacific regions.
