Clinical Laserthermia Systems AB (CLS) announced that the U.S. Food and Drug Administration has granted clearance for expanded labeling of the ClearPoint Prism® Neuro Laser Therapy System. The approval extends the system's compatibility beyond the existing 3.0 Tesla (3.0T) magnetic resonance imaging guidance to include 1.5T MRI guidance, significantly broadening accessibility for U.S. hospitals and patients.
Market Impact and Clinical Significance
The expanded clearance more than doubles the addressable U.S. market for Neuro Laser Interstitial Thermal Therapy (Neuro LITT) procedures. This substantial market expansion is based on the fact that approximately half of all MRI-guided neurosurgical procedures are performed using 1.5T scanners, according to research published in Frontiers in Physics.
"This FDA clearance is a pivotal milestone for CLS and our partner Clearpoint Neuro," commented Dan J. Mogren, CEO of CLS. "By expanding compatibility to 1.5T MR scanners, we are unlocking access to minimally invasive laser ablation therapy for a much larger number of patients and hospitals across the U.S."
Technology and Partnership
The ClearPoint Prism® Neuro Laser Therapy System is designed for minimally invasive treatment of neurological conditions through image-guided laser ablation. The system is marketed and sold exclusively in the U.S. by ClearPoint Neuro, Inc., under the companies' global partnership agreement.
The expanded labeling enables hospitals equipped with both 3T and 1.5T MRI scanners to treat a larger range of patients with severe neurological conditions. This compatibility enhancement is expected to accelerate adoption and clinical use of Neuro LITT procedures across a broader range of medical facilities.
Strategic Positioning
Mogren emphasized the strategic importance of the clearance, stating it represents "a major step in our mission to enable broader adoption of Neuro LITT procedures and to support physicians with safe, effective, and image-guided solutions for treating patients with severe neurological conditions."
The FDA clearance follows CLS's submission of a 510(k) application in April 2025, marking a key milestone in the company's strategic partnership with ClearPoint Neuro. The expanded indication allows the system to include both 3.0T and 1.5T MRI guidance in its labeling, providing healthcare providers with greater flexibility in treatment planning and execution.
CLS develops and sells the TRANBERG® Thermal Therapy System and ClearPoint Prism® Neuro Laser Therapy System with sterile disposables for minimally invasive treatment of cancer tumors and drug-resistant epilepsy. The company is headquartered in Lund, Sweden, with subsidiaries in Germany, the United States, and a marketing company in Singapore.
