Subjects: PDT, FDA
YourBio Health's TAP® Micro Select Secures FDA 510(k) Medical Device Clearance for Producing Capillary Whole Blood Samples
Virtually painless approach, leveraging HALO technologytm, improves patient access, affordability, and accuracy in decentralized clinical trials with greater flexibility for health and wellness testing
Adding to the YourBio Health portfolio, TAP® Micro Select, now commercially available, becomes next FDA cleared device
BOSTON, April 24, 2023 /PRNewswire/ -- YourBio Health, Inc, the developers of the world's first virtually painless push-button blood collection device, announced today that TAP® Micro Select received 510(k) Medical Device clearance from the U.S. Food and Drug Administration (FDA). Touch Activated Phlebotomy (TAP®) was developed over the last 15 years to deliver on the goal of developing both painless and remote blood collection.
YourBio Health received FDA clearance in 2019 for the first bladeless lay-person-use device for microcapillary blood diagnostic testing using TAP® technology. Adding to the existing CE-marked TAP® II device, and TAP® Micro1, TAP® Micro Select uses the same bladeless, high-volume liquid blood collection technology. As measured by independent labs' usability studies2, this technology is significantly preferred by end-users to venipuncture, fingerstick, and competitive devices.
TAP® Micro Select is ideally suited for use in decentralized clinical trials and health and wellness testing by reducing barriers to blood collection. Using HALOtm technology, a bladeless microneedle array, TAP® Micro Select delivers virtually painless, large volume collection of up to 500uL of whole, capillary high-quality blood.
"YourBio Health is advancing virtually painless blood collection technologies to meet the growing demand in various blood sampling markets," said Harry Wilcox, Chairman and CEO of YourBio Health and Partner, Flagship Pioneering. "Independent research using TAP® technologies has demonstrated venous concordance for patient-centric collection meeting the desires of both patients and clinicians; this includes promoting greater diversity in clinical trials and supporting the momentum behind the mega-trend of people wanting to understand and have more control of their health."
About YourBio Health
Since 2007, YourBio Health eliminates barriers to blood collection by allowing a patient blood sample to be produced without the pain of a fingerstick or need for traditional phlebotomy. We enable the decentralization of clinical trials and provide access to companies who offer wellness testing for consumers with innovative TAP® Technologies. They are virtually painless, easy-to-use, and enable the collection of a blood specimen. Backed by the latest science, data management technology, and certified central laboratories, we guarantee satisfaction. Learn more at www.yourbiohealth.com
YourBio Health was founded by Flagship Pioneering, which conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $100 billion in aggregate value.
1TAP® Micro is not US 510k cleared.
2Data on file
SOURCE YourBio Health
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