Seventh Sense Biosystems Inc (7SBio), Medford, Mass, has received FDA premarket notification (510(k)) clearance for its TAP blood collection device.
“No one likes getting blood drawn, but blood is the single-most important source of medical information in healthcare today, with about 90% of all diagnostic information coming from blood and its components,” says Howard Weisman, CEO of 7SBio. “TAP has the potential to transform blood collection from an inconvenient, stressful, and painful experience to one people can do themselves anywhere, making health monitoring much easier for both healthcare professionals and patients.”
TAP is placed on an individual’s upper arm, and blood collection starts with a simple press of a button. The process typically takes 2–3 minutes.
The current clearance allows healthcare workers to use TAP to collect capillary blood for hemoglobin A1c (HbA1c) testing, which is routinely used to monitor blood sugar levels in diabetic or prediabetic patients. 7SBio is working with FDA to expand the use of TAP to add additional tests. The company plans to develop and commercialize future versions of TAP that will enable consumers to collect their own blood anywhere and anytime.
“It’s shocking that with all of the healthcare innovation we’ve seen in the past few decades, blood collection has lagged so far behind and is still a primitive and difficult process for so many people,” says Robert Langer, cofounder of 7SBio. “I, and so many people I know, have always disliked needles, so it’s exciting and fulfilling to receive FDA clearance after a terrific effort by our team. We had the opportunity to take our idea and create a device that fundamentally transforms the way blood is drawn, using microneedles smaller than an eyelash.”
For more information, visit 7SBio.