The California-based firm also announced the first-in-human cases using the integrated system and the publication of a key validation trial for its ClearPoint Maestro Brain Model
FDA grants clearance to ClearPoint 2.2 Software with Maestro Brain Modeling. (Credit: Milad Fakurian on Unsplash)
ClearPoint Neuro, a company focused on offering precision navigation to the brain and spine, has received the US Food and Drug Administration (FDA) clearance for its ClearPoint 2.2 Software with integrated Maestro Brain Modeling.
The California-based firm also announced the first-in-human cases using the integrated system and the publication of a key validation trial for its ClearPoint Maestro Brain Model.
ClearPoint Maestro Brain Model is an anatomical segmentation analysis tool. ClearPoint Neuro has developed the software in partnership with Philips.
The tool is designed to automate the process of identification, labelling, and measuring the size and form of brain structures that are visible in magnetic resonance imaging (MRI) scans.
The ClearPoint Maestro Brain Model is said to employ a novel approach that blends machine learning, dynamic shape models, and deformable surfaces. It was granted 510(k) clearance by the FDA in August 2022.
ClearPoint Neuro CEO and president Joe Burnett said: “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.
“At the same time, we are pleased to announce 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.
“The first clinical cases using ClearPoint 2.2 were completed successfully this quarter, and we expect full market release in the second half of this year.”
ClearPoint Neuro’s portfolio includes the FDA-cleared and CE-marked ClearPoint Neuro Navigation System.
Last month, the medical technology company secured FDA clearance for its SmartFrame OR Stereotactic System.