SOLANA BEACH, Calif. - ClearPoint Neuro, Inc. (NASDAQ:CLPT), a company specializing in precision navigation for brain and spine procedures, has announced the FDA clearance of its ClearPoint 2.2 Software, featuring integrated Maestro Brain Modeling. This development, alongside the publication of a validation study in the journal NeuroImage, marks a significant advance in the field of MRI-guided neurological interventions.
The ClearPoint 2.2 Software is designed to enhance surgical planning and execution by providing rapid, accurate, and reproducible segmentation of brain structures. This is crucial for identifying targets and safety zones during procedures such as cell and gene therapy delivery, laser ablation, biopsy, and deep brain stimulation. The first clinical cases using the new software were successfully completed earlier this quarter, with a full market release anticipated in the second half of this year.
The validation study published in NeuroImage introduces the methodology behind the Maestro Brain Model's shape-constrained deformable brain segmentation, a feature that has been cleared by the FDA. The study compares the performance of the Maestro Tool with manual expert segmentation and FreeSurfer, an open-source alternative. The results indicate that Maestro offers superior performance in terms of accuracy and reproducibility, making it an ideal tool for MRI-guided neurosurgical interventions.
ClearPoint Neuro's portfolio includes the FDA-cleared and CE-marked ClearPoint Neuro Navigation System, and the company collaborates with healthcare and research centers globally. Their services extend to supporting clinical procedures and providing preclinical development services for controlled drug and device delivery.
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