Health technology firm Seventh Sense Biosystems has started a pivotal registration trial of its TAP100 Touch Activated Phlebotomy device.
About 120 subjects will be recruited in the trial at three hospitals in the Northeast US.
The company plans to file marketing authorization for the device in the US and the European Union in the second quarter of this year. It is expected to be cleared in both the regions later this summer.
Designed to use across a spectrum of diagnostic applications, TAP is a platform that draws capillary blood in a painless and one-step process without having to puncture a vein or lance a fingertip.
The TAP system perforates only the uppermost layers of skin using virtually invisible micro-needles, and collects capillary blood using a new microfluidic extraction process.
The device features visual indicator to confirm when collection is complete, while the blood is stabilized with an anticoagulant, if required.
According to the company, the TAP platform is being developed to collect and transport blood for diagnostic testing using multiple top analytical platforms on the market.
Seventh Sense Biosystems CEO Howard Weisman said: "We are excited to begin the registration trial with the company’s lead product, the innovative TAP100 blood collection device.
"Under the current system, anyone giving blood for diagnostic tests has to undergo a procedure that is inconvenient, scary and painful."
Image: The TAP100 Touch Activate Phlebotomy device painlessly collects 100 microliters of capillary blood for diagnostic testing at the touch of a button. Photo: courtesy of PRNewsFoto / Seventh Sense Biosystems.