ClearPoint Neuro, Inc. announced FDA Clearance and first-in-human cases using the ClearPoint 2.2 Software with integrated Maestro Brain Modeling, and also the publication of a key validation study for its ClearPoint Maestro®?Brain Model in the peer-reviewed journal NeuroImage. 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. At the same time, announced that one of many planned validation studies has been published online in the journal NeuroImage to give surgeons confidence in the performance and accuracy of the Maestro Tool.

MRI-guided neuro interventions require rapid, accurate, and reproducible segmentation of anatomical brain structures for identification of targets during surgical procedures. 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. Quantitative analysis indicates superior performance compared to both manual expert segmentation and Free Surfer.

The shape-constrained methodology results in accurate and highly reproducible segmentation.