FDA Approved Seventh Sense Device for Enclosed Blood Collection

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U.S. FDA approved Seventh Sense Biosystem’s TAP phlebotomy device in February 2017 for use in hemoglobin A1c (HbA1c) testing.

The enclosed device system acts as both needle and vial. It is expected to be approved for use without a trained specialist as well. The device is operated through placing on the upper arm. With a push of a button, an array of tiny microneedles pierces the skin. A vacuum chamber within the device painlessly draws the blood from the pierced capillaries. The blood is mixed with an anticoagulant. Two or three minutes later, TAP switches off and the device is sent to the laboratory for testing.

Multiple vials can be used due to different tests require different anticoagulants irrespective of sample volumes. “The instruments don’t require that much blood to do their analysis. That’s because the technology has advanced significantly in the last 40 years. But the blood collection process remains largely unchanged,” said Howard Weisman, CEO of the company. Seventh Sense hopes to have a wide range of single-use tests on the market, categorized by the anticoagulant inside the chamber in near future. “At some point in the future, a TAP device may be all you need for a vast number of tests,” Weisman said. “But for today, we’ve been cleared for one and we’re working on others.”

However, the company did not disclose price for the products and the price would initially be rolled out as a package offered to established partners in the space. The company believes it can significantly reduce the cost of the procedure especially when the cost of phlebotomists’ time is factored in. The company plans to launch TAP over the coming months, while also working to broaden its FDA clearance. “We’re talking to the FDA about home use. We certainly want to be able to offer that in the future,” Weisman said.

According to Blood Collection Devices Market report published by Coherent Market Insights, blood collection devices plays a crucial role in the patient treatment. For the treatment, blood samples are collected to measure the basic metabolism components such as blood urea nitrogen, sodium, potassium, creatinine, magnesium, chloride, and also used to measure blood glucose and lipid levels. In 2015, Velano Vascular gained market approval for its blood-draw technology, which is well-suited to the hospital setting. The device is now marketed throughout the U.S.

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