Clinical Laserthermia Systems AB $(CLS)$ has announced that the U.S. Food and Drug Administration (FDA) has granted expanded clearance for its ClearPoint Prism® Neuro Laser Therapy System. The approval now allows the system to be used with both 3.0T and 1.5T MRI scanners, significantly broadening its accessibility for U.S. hospitals and patients. This regulatory milestone more than doubles the addressable U.S. market for Neuro Laser Interstitial Thermal Therapy (Neuro LITT) procedures, facilitating accelerated adoption of the technology in neurosurgery. The first installations of the 1.5T labeled system are expected in the fourth quarter of this year. The approval is specific to CLS and its ClearPoint Neuro partnership.
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