ClearPoint Neuro, Inc. announced that it has obtained 510(k) clearance for version 2.1 of the ClearPoint Neuro Navigation software. Version 2.1 of the ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology.

These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners. The main customer benefits of the 2.1 software include optimizing ease of use for clinicians, enhancing visualization of medical image datasets, providing a new set of trajectory planning tools, introducing new workflow tools for gene therapy clinical trials, and numerous performance and technical improvements which will help to streamline and optimize the clinical workflow.

The software is currently in limited market release and will be deployed initially to ClearPoint customers who participate in the ClearPoint “Pathfinder” Program. Pathfinder is designed to support and cultivate first-hand discovery of innovative developments that may facilitate optimal patient care by providing participating customer sites with access to ClearPoint Neuro's cutting-edge technology.