FDA clears ‘painless’ blood draw device

The U.S. Food and Drug Administration (FDA) has issued initial 510(k) clearance for a new blood collection device billed by its makers as “virtually painless.”

The TAP device, marketed by Seventh Sense Biosystems, creates a vacuum seal on the skin and uses a push-button to insert a hidden group of tiny needles. The needles draw blood from the capillaries, without the need for a vein puncture, fingerstick or tourniquets.

The blood collection unit is intended for one-time use and acts as its own receptacle for holding the blood sample. Lithium heparin serves as an anticoagulant.

Initially designed for diabetics, clinicians are hoping the technology can be adapted for other types of blood collection, including the ability to use multiple tube reservoirs for larger collections and more testing platforms.

"Now that we are cleared, we're working on new versions which will expand the test menu, as well as add-on accessories to increase stability and transport. We also intend to go back and get an 'at home' claim to enable patients to use TAP on their own," Stuart Blitz, Seventh Sense Biosystems’ Chief Business Officer, told MedPage Today.

Topics: Clinical