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# ClearPoint Neuro Brain Visualizer Cleared
- URL: https://www.fdaweb.com/clearpoint-neuro-brain-visualizer-cleared/
- Published: 2022-08-11T12:00:00.000Z
- Updated: 2026-09-14T17:55:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152496

FDA has cleared a ClearPoint Neuro 510(k) for its ClearPoint Maestro Brain Model, software for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. “The current version will enable reproducible analysis of patient data which will provide immediate value for our current and future biologics and drug delivery partners as they study volumetric infusion characteristics and longitudinal patient comparisons as part of their safety and pivotal trials,” the company says.

It asserts that the software will “quantify drug delivery using intraoperative imaging and simulate patient-specific infusions in targeted brain regions. The unique shape representation in Maestro will provide reproducible lead placement for deep brain stimulation and micro electrode recording. Surface meshes of segmented anatomical regions will define safety zones and optimal trajectories for patient-specific laser ablations.”