ClearPoint Neuro Announces FDA Clearance and First-in-Human Cases Performed with the New 2.2 Software Version and the Integrated Maestro Brain Model
“The Maestro Brain Model, and its integration into the recently FDA cleared ClearPoint 2.2 navigation software, is our latest example of just that.
- “The Maestro Brain Model, and its integration into the recently FDA cleared ClearPoint 2.2 navigation software, is our latest example of just that.
- The ClearPoint system can now offer fast, peri-procedural segmentation of the cortical structures of the brain to identify both targets and safety zones for cell and gene therapy delivery, laser ablation, biopsy and deep brain stimulation.
- This manuscript introduces the methodology for shape-constrained deformable brain segmentation behind Maestro, describes the validation performed for its FDA clearance, and presents a comparison with manual expert segmentation and FreeSurfer, an open-source segmentation software.
- Reproducibility error of Maestro (green), FreeSurfer 7.2 (blue) and manual segmentation (red) for common brain structures (left), and average over all structures (right).