ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system.
Solana Beach, California-based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand.
SmartFrame OR offers stereotactic guidance for the placement and operation of instruments or devices in neurological procedures. It helps during the planning and operation processes of these procedures, performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placements and electrode introduction.
ClearPoint Neuro’s ClearPointer works in conjunction with SmartFrame OR and a compatible stereotactic optical navigation system. It helps with patient registration and navigation.
SmartFrame OR can be used with or without available bone screw fiducials. ClearPoint Neuro plans to begin a limited market release of the system in the first half of 2024. It earmarked the second half of 2024 for a full market release.
“Expanding ClearPoint’s portfolio beyond the MRI into the operating room is of key strategic significance to the company in 2024 and beyond,” said Joe Burnett, president and CEO at ClearPoint Neuro. “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.”