YourBio Health
Boston (ots/PRNewswire)
A virtually painless approach utilizing HALO Technology™ improves patient access, affordability and accuracy in decentralized clinical trials with greater flexibility for health and wellness testing
Now commercially available, the TAP ® Micro Select expands the YourBio Health portfolio and is the next FDA-cleared device
YourBio Health, Inc., the developer of the world‘s first virtually painless push-button blood collection device, today announced that TAP ® Micro Select has received 510(k) medical device clearance from the US Food and Drug Administration (FDA). Touch Activated Phlebotomy (TAP®) was developed over the last 15 years to achieve the goal of painless and remote controlled blood collection.
YourBio Health received FDA clearance in 2019 for the first consumer bladeless microcapillary blood testing device with TAP® technology. In addition to the CE-marked TAP® II and TAP ® Micro 1 devices, the TAP ® Micro Select uses the same bladeless, high-volume liquid blood collection technology. According to usability studies by independent laboratories 2 , this technology is clearly preferred by end users over venipuncture, finger sampling and devices from other manufacturers.
TAP ® Micro Select is ideal for use in decentralized clinical trials and health and wellness testing as it reduces the barriers to blood collection. Using HALO™ technology, a bladeless microneedle array, TAP® Micro Select enables virtually painless, large-volume collection of up to 500uL of high-quality capillary blood.
“YourBio Health is driving the development of virtually painless blood collection technologies to meet growing demand in various blood collection markets,” said Harry Wilcox, Chairman and CEO of YourBio Health and a partner in Flagship Pioneering. “Independent research using TAP® technologies has shown that venous concordance satisfies the desires of patients and clinicians for patient-centric sensing, including encouraging greater diversity in clinical trials and supporting the megatrend of people wanting to better understand and control their health.”
Information about YourBio Health
Since 2007, YourBio Health has broken down blood collection hurdles by enabling the collection of a blood sample without the pain of a finger prick or the need for a traditional phlebotomy. We enable the decentralization of clinical trials and provide access to innovative TAP ® technologies for companies providing consumer wellness testing. They are virtually painless, easy to use and allow a blood sample to be taken. Backed by the latest science, data management technology and certified central laboratories, we guarantee satisfaction. You can find more information on: www.yourbiohealth.com
YourBio Health was founded by Flagship Pioneering, a company that conceives, founds, funds and develops innovative bioplatform companies to improve human health and sustainability. Since its founding in 2000, through its Flagship Labs division, the company has applied its unique hypothesis-driven innovation process to create and advance more than 100 scientific ventures, totaling over $100 billion in value.
1 TAP ® Micro is not US 510k approved.
2 data in the file
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Press contact:
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Original content from: YourBio Health, transmitted by news aktuell