ClearPoint Neuro, Inc. announced that its ClearPoint Prism® Neuro Laser Therapy System received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance expands the system's compatibility to include 1.5T MRI guidance.
The Prism system was previously cleared only for 3T MRI guidance. This expanded labeling is expected to significantly increase the market opportunity for ClearPoint Prism within the United States, where 1.5T MRI systems account for approximately 60% of clinical use.
Globally, 1.5T systems represent over 70% of the installed MRI base, positioning ClearPoint Prism for future international growth. This regulatory approval allows ClearPoint Neuro to address a much broader segment of the neurosurgery market with its laser therapy solution.
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