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ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that the ClearPoint Prism® Neuro Laser Therapy System ("ClearPoint Prism") received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include 1.5T MRI guidance in addition to the previously cleared 3T MRI guidance.
This expanded labeling could significantly increase ClearPoint Prism's market opportunity within the United States, where 1.5T MRI systems account for approximately 60% of clinical use.1 As the Company considers future development within key markets, 1.5T systems represent over 70% of the global installed MRI base,2 well-positioning ClearPoint Prism for future growth as the company continues to expand internationally.
Posted In: CLPT
