ClearPoint Neuro, Inc., in collaboration with its partner Clinical Laserthermia Systems, announced the submission of data to the FDA. The submission aims to expand the labeling of the ClearPoint Prism® Neuro Laser Therapy System.
The proposed expansion seeks to include compatibility with 1.5T MRI scanners, which would significantly broaden the system's addressable market. Currently, the Prism system is limited to use with 3 Tesla MRI scanners.
Expanding compatibility to 1.5T MRI scanners is a strategic move, as these systems represent a substantial portion of the installed MRI base in clinical settings. This initiative is expected to enhance the market opportunity for the Prism system.
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