Clinical Laserthermia Systems receives FDA 510(k) clearance for its MR guided laser ablation system in neurosurgery and initiates commercialization
Lund, Sverige – Clinical Laserthermia Systems AB (publ) (CLS) today announced that its second generation TRANBERG® Thermal Therapy System with Thermoguide™ Workstation has received 510(k) clearance from the US Food and Drug Administration (FDA). The clearance marks a breakthrough in the field of neurosurgery and for minimally invasive treatments of brain lesions that will now be performed more efficiently and safely. The system will be commercialized by CLS’s global distributor ClearPoint Neuro, Inc (Nasdaq:CLPT).CLS’s 510(k) clearance was achieved thanks to a close collaboration with CLS’s