BSD Medical Corporation (NASDAQ: BSDM) (Company or BSD) today reported that the Company has received certification that the MicroThermX Microwave Ablation System (MTX-180) meets all requirements for safety and performance needed for compliance with the IEC 60601-1, safety standard, "Medical Electrical Equipment Part 1: General Requirements for Safety." IEC 60601-1 is the global benchmark for safety of medical equipment and is a crucial tool for demonstrating compliance with regulatory requirements around the world, including the requirements for CE Marking and FDA clearance. Receipt of this certification will allow BSD to add the TUV safety mark to the MTX-180 system. Nearly all hospitals and clinics in the U.S. require a safety mark on equipment prior to purchase.
“We are excited to have completed this important step toward marketability of the MTX-180.”
"The receipt of this safety certification for the MTX-180 is a significant milestone for the Company and critical for marketing the MTX-180 system in the U.S. and Europe, as well as in most markets throughout the world," stated Harold Wolcott, President of BSD. "We are excited to have completed this important step toward marketability of the MTX-180."
TÜVRheinland® performed independent testing of all components and operations of the MTX-180 and performed an on-site assessment of BSD's internal control systems for ensuring product quality before it accredited the MTX-180. TÜVRheinland is a nationally recognized testing laboratory and is recognized as a U.S. National Certification Body by the International Electrotechnical Commission.