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# ClearPoint Neuro Navigation Software Cleared
- URL: https://www.fdaweb.com/clearpoint-neuro-navigation-software-cleared/
- Published: 2022-09-19T12:00:00.000Z
- Updated: 2026-09-14T17:59:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152769

FDA has cleared a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software. The software provides stereotactic guidance for placing and operating instruments or devices during planning and operation of neurological procedures using MRI scanners (biopsies, catheter and electrode insertion, including deep brain stimulation lead placement), the company says. The device is intended for use only with 1.5 and 3.0 Tesla MRI scanners. The 2.1 software is designed to improve visualization of medical image datasets, provide a new set of trajectory planning tools, new workflow tools for gene therapy clinical trials, and numerous performance and “technical improvements which will help to streamline and optimize the clinical workflow,” ClearPoint says.