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Regulatory Affairs / Submissions and Approvals

Seventh Sense Biosystems’ Phlebotomy Platform Wins CE Mark

Nov. 12, 2013

EU health regulators have granted Seventh Sense Biosystems CE Mark approval for its Touch Activated Phlebotomy blood-collection system. The system is meant to replace the simpler but messier finger-prick method.

The company currently is working to resolve “minor points of clarification” in its submission to the FDA and anticipates PMA approval within the next few months, Senior Vice President Tim Richards said.

Seventh Sense’s device is the size of a stethoscope and can be placed on the forearm. A small green button activates microscopic needles that prick a patient’s skin, drawing in approximately 10 mL to 20 mL of blood using a vaccuum chamber; this blood can then be transferred to a laboratory for analysis.

Richards emphasized that the collection device represents an advance over the traditional finger-prick method in that patients experienced “near to no pain” from the device’s needles.

“The high discharge velocity of the microneedles is something that has not been achieved before,” he said, adding that the company is working on developing a version of the device that can also analyze the blood sample that it draws.

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