DxTx Medical Secures Quality Certifications & Manufacturing Capabilities for MRI Endorectal Product Line
PITTSBURGH, PA, March 31, 2020 – DxTx Medical announces the completion of MDSAP certification to ISO 13485:2016, including FDA, TGA, and Health Canada requirements, as well as product certification to MDD 93/42EEC Annex II Full Quality Assurance.
DxTx Medical is a medical device manufacturer of products that enable enhanced radiology applications by enabling high-resolution imaging of the prostate and surrounding anatomy. The eCoil product interfaces with GE, Siemens, and Phillips MRI scanners around the world, offering enhanced imaging for prostate exams.
DxTx acquired the eCoil product line from Bayer in August of 2019. While this product has been in the global healthcare market for more than 20 years, DxTx Medical is investing in upgrading interface device capabilities for newer platforms of MRI scanners.
“Securing these certifications assures end-users have the capability to provide high quality products and services to their patients,” said DxTx Medical’s Chief Commercial Officer, Joseph Habovick. “It establishes our licensing and distribution infrastructure both inside and outside the U.S.”
The newly manufactured and branded DxTx Medical products are currently ready for distribution in the United States, Canada, and additional countries around the world.
“It is our goal to be a critical resource to the radiology industry by providing technology that enhances the ability to provide the best treatment options for patients,” said Xueli Wang, CEO and President of DxTx Medical. “Getting our manufacturing process to this level of quality in such a short time reflects the capabilities of our team to meet this goal and grow our company to the next phase”
About the MR Endorectal Coil
The MR Endorectal Coil provides a high signal-to-noise ratio (SNR), which enables the sensitivity needed for multi-parametric and spectroscopy imaging, on 1.5 and 3.0T MRI scanners. The small field of vision and high spatial resolution images with the endorectal coil can assist the radiologist by delivering improved sensitivity and specificity in diagnosis and aid in treatment planning.
About DxTx Medical
DxTx Medical (www.dxtxmedical.com), located in O’Hara township outside of Pittsburgh, Pennsylvania, is a growing medical device company operated by industry veterans who are already well versed in medical devices such as the eCoil MR Endorectal coil. For more information call 1.833.777.3989 or email [email protected].