ClearPoint Neuro, a global device, cell, and gene therapy-enabling company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SmartFrame OR stereotactic system for brain and spinal treatment navigation.
The system consists of two main components, SmartFrame OR and ClearPointer Optical Navigation Wand. SmartFrame OR provides stereotactic guidance for the placement and operation of instruments or devices during planning. This includes the operation of neurological procedures performed along with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement, and electrode introduction.
ClearPointer is used in conjunction with SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. SmartFrame OR may be used with or without available bone screw fiducials.
ClearPoint said it plans to begin limited market release in the first half of 2024, with a planned full market release in the second half of the year.
