CLS Submits CE-Mark Application for ClearPoint Prism Neuro Laser Therapy System
Clinical Laserthermia Systems AB (CLS) has submitted a CE-marking application for its ClearPoint Prism Neuro Laser Therapy System, seeking European regulatory approval for use in neurosurgery. The application follows CLS’s 2024 ISO-certification under the European Medical Device Regulation (MDR) and a successful clinical study at Skåne University Hospital. Regulatory approval is expected in the second half of 2026.
Clinical Laserthermia Systems AB (CLS) has submitted a CE-marking application for its ClearPoint Prism branded Neuro Laser Therapy System, seeking European regulatory approval for use in neurosurgery. The company aims to expand its market presence outside the U.S. and provide MRI-guided neuro laser ablation technology to European patients in need of less invasive neurosurgical options. The application follows CLS’s 2024 ISO-certification under the European Medical Device Regulation (MDR) and a successful clinical study at Skåne University Hospital, which demonstrated increased median survival for patients with recurrent malignant brain tumors treated with the technology compared to open surgery. Regulatory approval through CE-marking is expected in the second half of 2026. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CLS - Clinical Laserthermia Systems AB published the original content used to generate this news brief via Cision (Ref. ID: 20251202:BIT:9387:0) on December 03, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
