Image: ClearPoint Maestro Brain Model has received FDA clearance (Photo courtesy of ClearPoint Neuro)
A new anatomical segmentation analysis tool is capable of automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. The software is intended to automate the process of identifying, labeling, and quantifying the volume and shape of brain structures visible in MRI images.
The first-generation anatomical segment analysis tool developed by ClearPoint Neuro, Inc. (Solana Beach, CA, USA) in partnership with Royal Philips (Amsterdam, Noord-Holland) emerged over 10 years ago from research aimed at detecting subtle volumetric and shape abnormalities in patients with mild traumatic brain injury. The ClearPoint Maestro Brain Model uses a unique methodology that combines deformable surfaces with active shape models and machine learning. More importantly, it provides point-based correspondence longitudinally and across patients. Cross-validation on more than 1,000 scans demonstrate highly reproducible results with sub-millimeter accuracy and normative values from 560 healthy subjects provide reference ranges for patient-specific assessments. The ClearPoint Maestro Brain Model has received 510(k) clearance.
“This is a tremendous milestone for ClearPoint and our collaboration with Philips as we are thrilled to introduce this new commercial tool into our portfolio,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “This is a crucial first step in our path to make the Maestro Brain Model the ‘engine’ in our navigation system supporting multiple new applications in the future. Now that the standalone patient analysis tool is cleared, our development team will work to embed this software directly into the ClearPoint Navigation platform and add new functionality based on the priorities of the business.”
“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,” commented Lyubomir Zagorchev, Vice President of Clinical Science and Applications at ClearPoint Neuro. “However, the goal of our future applications once embedded into the ClearPoint Navigation software will enable more advanced patient-specific target identification and trajectory planning across all ClearPoint applications. Our plan is to 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. This is really just the beginning of what is possible and we are excited to execute the limited market release of this product through the end of 2022.”
ClearPoint Neuro, Inc.