Seventh Sense Biosystems, a company based outside of Boston, MA, won FDA clearance for its TAP device to be used by laypersons to collect blood. Moreover, the device is now cleared to be used at home by individuals for “wellness testing,” according to the company.
“We’re very excited about this clearance since it represents an unprecedented landmark event in healthcare and, more importantly, has the potential to significantly improve patient outcomes,” said Rick Bente, CEO of 7SBio. “We believe that TAP will transform blood collection from an inconvenient, stressful, and painful experience to one where users can perform nearly painless blood collection themselves anywhere. The company aims to make monitoring much easier for both healthcare professionals and patients without sacrificing the accuracy of standard lab testing.”
The sing-use device features microneedles that penetrate the skin without causing significant pain, unlike large needles that can be both painful and frightening. It is only a few centimeters in diameter and can draw up to 100 micro liters of whole blood, which is sufficient for many clinical lab tests.
It is placed on the upper arm and allowed a few minutes to draw blood into itself, releasing anticoagulants if necessary to make sure the blood draw continues uninterrupted. The patient doesn’t see any needles or the blood collecting inside the device. If not told what the device really is, kids may not even realize that their blood is being taken.
Product page: TAP device…