Seventh Sense Biosystems said today its Tap blood collection device won FDA 510(k) clearance.
The company’s push-botton device collects capillary blood for hemoglobin A1C testing without the use of large needles. The Tap device is designed to be placed on the upper arm and blood collection, which takes 2 to 3 minutes, begins with a push of a button, according to Seventh Sense.
“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,” CEO Howard Weisman said in prepared remarks. “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.”
The company said it is working with the FDA to expand the device’s indication to include additional tests, including “at home” tests. Seventh Sense anticipates that it will develop and commercialize future versions of the device that will allow consumers to collect their own blood anywhere.
“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,” co-founder Robert Langer said. “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.”
“We’re thrilled to receive FDA clearance so patients can benefit from a much-improved experience and providers can streamline the blood collection process,” Weisman added. “It’s also just the beginning as we plan to expand our product offerings with the ultimate goal of making TAP the go-to tool for at-home blood collection.”