YourBio Health's TAP® Micro Select Secures FDA 510(k) Medical Device Clearance for Producing Capillary Whole Blood Samples

Virtually painless approach, leveraging HALO technology™, 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 – 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 HALO™ 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

YourBio Health is a Flagship Pioneering portfolio company that invented ‘Touch-Activated Phlebotomy’ (TAP) for virtually painless whole capillary blood collection using devices incorporating patented technology. This technology eliminates barriers to blood collection by allowing a capillary blood sample to be collected from any physical location without the pain of a fingerstick or the need for traditional phlebotomy. Backed by the latest sciences, data management technology, and certified central laboratories, YourBio Health is seeking to revolutionize and humanize the blood collection process serving clinical trials, and diagnostic and wellness applications.

Media Contact:
Connor Halverson
That’s Nice LLC, on behalf of YourBio Health
Tel: +1 212 366 4455
Email: connor@thatsnice.com

SOURCE YourBio Health