ClearPoint System (Software Version 3.0)

The ClearPoint System (Software Version 3.0) is a Class II neurological stereotaxic instrument designed to offer precise, real-time guidance for interventional neurological procedures. It achieves this by integrating advanced intraoperative CT imaging with existing MR-guided capabilities, enhancing surgical navigation for applications like biopsies and deep brain stimulation, validated through comprehensive non-clinical testing.

ClearPoint Neuro, Inc. has received authorization to market its ClearPoint System (Software Version 3.0), which has been determined to be substantially equivalent to previously available devices. Classified as a Class II neurological stereotaxic instrument, this system is intended to provide stereotactic guidance for the precise placement and operation of instruments or devices during neurological procedures. This allows ClearPoint Neuro, Inc. to make the device available for clinical use, subject to standard regulatory controls. The updated ClearPoint System (Software Version 3.0) introduces key advancements, primarily the integration of intraoperative CT imaging capabilities alongside its existing MR-guided functionalities. The system includes a workstation with planning and monitoring software, as well as physical components such as the SMARTGrid Planning Grid and SMARTFrame Trajectory Frame, designed to assist in surgical navigation. Comprehensive non-clinical testing, including accuracy verification for both MRI and CT guidance, confirmed that the software modifications did not compromise safety or effectiveness, demonstrating compliance with all design specifications. The system is indicated for procedures like biopsies and the insertion of catheters and electrodes, including those for deep brain stimulation.

AI Regulatory Concerns

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• Q1. What are the specific quantitative accuracy metrics for both MRI and CT guidance demonstrated in the non-clinical testing, and how do they compare to previous versions or competing systems?; How does the integration of intraoperative CT imaging specifically improve surgical workflow, target localization, and patient outcomes compared to MR-only guidance for different neurological procedures?; What are the training requirements and potential learning curve for clinicians adopting the ClearPoint System (Software Version 3.0) with its new multi-modality imaging capabilities?; Beyond deep brain stimulation, what other novel or complex neurological procedures can significantly benefit from the enhanced precision offered by this updated stereotaxic system?; What post-market surveillance or clinical studies are planned to further validate the long-term safety, effectiveness, and clinical utility of the ClearPoint System (Software Version 3.0) in a broader patient population?