ClearPoint Neuro has earned 510(k) clearance from the U.S. Food and Drug Administration for its system designed to make brain and spinal surgeries more precise.
The SmartFrame OR and its ClearPointer optical navigation wand accessory together provide guidance for instrument placement during neurological procedures, such as biopsies and electrode introduction, all with the help of a CT or MR image of the patient done pre-operation.
“More than 95% of all stereotactic neuro-navigation procedures take place in the OR, supporting DBS, laser ablation, biopsy, sEEG and more,” Joe Burnett, president and CEO at ClearPoint Neuro said in a statement. “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.”
The company said it plans a full market release of the SmartFrame system in the second half of 2024. It will be made available for limited release in the coming months.
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