ClearPoint Neuro announces FDA clearance for SmartFrame OR system

ClearPoint Neuro announced it has received 510(k) clearance for its SmartFrame OR Stereotactic System. “Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the Company in 2024 and beyond,” stated Joe Burnett, President and CEO at ClearPoint Neuro. “More than 95% of all stereotactic neuro-navigation procedures take place in the OR, supporting DBS, Laser Ablation, Biopsy, sEEG, and more. This product is the first in ClearPoint’s history that does not require the use of MRI during the procedure, allowing us to access more hospitals, and to support an order of magnitude more patients than our legacy portfolio. Importantly, the SmartFrame OR is compatible with capital hardware and software already present in many neurosurgical operating rooms and should not require the approval by hospital capital committees for surgeons to try this new product.”