CLS has filed its 510 (k) application with the U.S. Food and Drug Administration (FDA) for the second generation of TRANBERG® | Thermal Therapy System with Thermoguide ™ Workstation.
Clinical Laserthermia Systems AB (publ) (CLS) announces today that the company has submitted its application for 510 (k) approval to the U.S. Food and Drug Administration (U.S. FDA) for the second generation of TRANBERG® | Thermal Therapy System with Thermoguide ™ WorkstationAs a result of very extensive work, carried out in close collaboration with our partner Clearpoint Neuro Inc. (formerly MRI Interventions), which included generation of complex ex-vivo and in-vivo data from bench and animal studies performed in accredited laboratories in USA, CLS has submitted its 510 (k) application to