GMED, a French Notified Body specialising in medical device assessments, issued the certification contract authorising the use of CE Marking for the blood collection device
GMED grants CE Marking for YourBio Health's TAP Micro Select blood collection device. (Credit: YourBio Health, Inc.)
YourBio Health, a US-based medical device company, has obtained further regulatory approval for its Touch-Activated Phlebotomy (TAP) Micro Select blood collection device with certification for CE Marking.
GMED, a French Notified Body specialising in medical device assessments, issued the certification contract authorising the use of CE Marking for the TAP Micro Select blood collection device.
The Flagship Pioneering portfolio company said that the expanded approval will continue to enhance the device’s approach to humanising the blood collection process.
The advancement promises benefits in clinical trials, that are crucial for the approval of essential new treatments. It also offers opportunities for home-based, patient-administered testing in the diagnostic and wellness product markets, said YourBio Health.
The HALO Technology developed by the company incorporates a bladeless microneedle array, providing a nearly painless experience for end-users in contrast to fingerstick, venipuncture, and competing devices.
In April 2023, the TAP Micro Select device secured the 510(k) medical device clearance from the US Food and Drug Administration (FDA) for producing capillary whole blood samples.
YourBio Health CEO Harry Wilcox said: “With our patented Halo technology within the TAP micro series of blood collection devices, YourBio Health is unique in offering virtually painless blood sample collection using a bladeless microneedle array.
“Regulatory approval will enable our device’s use with commercial blood collection tubes and allow use in kits that revolutionise blood testing in diagnostics and wellness.”
Wilcox further stated that the extended regulatory clearance will continue to bolster the shift towards decentralised clinical trials and the recruitment and retention of more diverse patient populations, especially those known to be more relevant for specific diseases.
Ultimately, this approach is expected to contribute to the success of essential new treatments and improve access to therapies for currently underserved and voluntarily hesitant patient groups, said the CEO of YourBio Health.
According to the company, remote, capillary whole blood collection presents an opportunity to substitute traditional venous blood collection and painful finger stick tests across various applications. This approach makes the blood collection process less intimidating for patients and facilitates home-based administration in numerous scenarios.
Besides, remote, capillary whole blood collection offers significant benefits in the design of clinical trials and enhances the appeal of products in diagnostic kits and wellness test applications, said YourBio Health.