CLS Submits CE-Mark Application for ClearPoint Prism Neuro Laser Therapy System
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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.
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