ClearPoint Neuro announces FDA submission to expand ClearPoint Prism labeling

ClearPoint Neuro (CLPT) announced its partner, Clinical Laserthermia Systems, completed the submission of its 510(k) application to the FDA, expanding the indication of the ClearPoint Prism Neuro Laser Therapy System to include 1.5 T MRI guidance. ClearPoint Prism has already seen rapid adoption across functional and oncological neurosurgical LITT procedures. ClearPoint Prism is currently indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under 3.0 T magnetic resonance imaging guidance in medicine and surgery in neurosurgery for a wavelength of 1064nm.