Yukon Medical Granted Formal Approval to Sell ClearTip™ Swabs in the European Union
DURHAM, N.C., May 18, 2021 – Durham-based medical device company Yukon Medical announced today that it has been granted formal approval to sell ClearTip™ swabs (specimen collection devices) in the European Union. The announcement comes four months after the domestic listing of ClearTip swabs with the US FDA.
Yukon Medical’s ClearTip swabs are manufactured from a medical-grade, biocompatible polymer molded in an ISO Class 8 medical cleanroom. The swabs have been designed to optimize the collection of upper respiratory samples while allowing the sample to be fully recovered without being absorbed into the swab. Over the past five months, the company has significantly increased manufacturing capacity for the swabs and can now supply millions of swabs per month.
Yukon Medical partnered with local medical device design, development and manufacturing company Gilero to assist in the development and testing of the ClearTip swab project. Gilero now handles swab packaging and manages sterilization at their manufacturing facility in Pittsboro, NC.
The company previously announced it was awarded funding from the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of the company’s ClearTip swabs. The RADx initiative seeks to significantly increase the number, type, and availability of COVID-19 tests by millions per week. The technologies supported by the program are expected to make a significant contribution to expanding the nation’s testing capacity. This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92021C00002.
To learn more about Yukon Medical and the Yukon ClearTip Swab, visit www.yukonmedical.com.