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FDA Clears “Virtually Painless” Blood Collection Device
The FDA has awarded 510(k) clearance to a new blood-collection device called TAP (Seventh Sense Biosystems). The walnut-sized device attaches to the patient’s arm with an adhesive strip, and uses a ring of 30 spring-loaded microneedles to puncture the skin and withdraw 100 mcL of blood—enough for most blood tests. The product’s manufacturer has described it as “virtually painless.”
The FDA’s approval allows health care workers to use the TAP device to collect capillary blood for hemoglobin A1c testing, which is routinely used to monitor blood sugar levels in diabetic or prediabetic patients. Seventh Sense Biosystems is working with the FDA to expand the use of TAP to add additional tests as well as at-home collection.
The company’s goal is to lead the “self-collection” movement––enabling blood collection to occur at home, much like the “self-diagnostic” shift in the 1980s when patients could finally perform diagnostic tests at home. The company plans to develop and commercialize future versions of TAP that will allow consumers to collect their own blood anywhere and anytime.