- ClearPoint Neuro (CLPT, Financial) and Clinical Laserthermia Systems submit 510(k) application to the FDA for 1.5 T MRI inclusion.
- Expansion expects to unlock over 50% of the U.S. neuro LITT market by the second half of 2025.
- The ClearPoint Prism system currently functions with 3.0 T MRI in neurosurgery.
ClearPoint Neuro, Inc. (CLPT) and its partner Clinical Laserthermia Systems (CLS) have initiated the process to expand the FDA labeling of the ClearPoint Prism Neuro Laser Therapy System to encompass 1.5 T MRI guidance. This strategic submission aims to significantly broaden market access, potentially unlocking over 50% of the U.S. neuro LITT market that remains untapped.
The ClearPoint Prism system, presently approved for soft tissue necrotizing or coagulation under 3.0 T MRI guidance, is utilized primarily in functional and oncological neurosurgical procedures. With the successful clearance expected in the latter half of 2025, the expanded label will allow the system to cater to a broader array of medical facilities equipped with 1.5 T MRI.
Joe Burnett, President and CEO of ClearPoint Neuro, emphasized the importance of this submission, highlighting the collaborative efforts with CLS to enhance the adoption and accessibility of the ClearPoint Prism system. CLS's CEO, Dan J. Mogren, echoed these sentiments, expressing pride in supporting ClearPoint Neuro's expansion in the neuro LITT market.
