Clinical Laserthermia Systems (CLS) said it's conducting new in vivo precision laser ablation treatment studies using its Tranberg thermal therapy system with MRI-guided Thermoguide thermometry software in neurological and prostate applications.
The Tranberg thermal therapy system is a small, mobile laser unit with monitoring capabilities and single-use products developed to enable precision laser ablation procedures using all types of image guidance, according to the vendor. It can control and monitor tissue temperatures within the ablation volume and the surrounding tissue.
The company said it currently expects to submit a 510(k) application for its technology to the U.S. Food and Drug Administration (FDA) during the first half of 2021. This timeline could be affected by the COVID-19 pandemic, however, CLS said.
In April, CLS obtained European Union approval and a European Commission certificate for its Tranberg system, Thermoguide software, and related products to be marketed and sold in Europe for indications such as prostate cancer, brain tumors, and epilepsy.
