FDA Clears Brain Modeling Software for Evaluation of Brain Volumetric and Other Changes
The Food and Drug Administration (FDA) granted clearance to a diagnostic platform (Maestro Brain Model; ClearPoint Neuro, Solana Beach, CA) for individuals with a suspected traumatic brain injury (TBI). This software quantifies and labels the shape and volume of brain structures from MRI images.
In development for more than 10 years, the software was designed to detecting subtle volumetric and shape abnormalities in individuals with mild TBI using calculations of deformable surfaces with active shape models and machine learning. Normative values were developed from a sample of 560 healthy subjects and cross-validation showed highly reproducible results across over 1,000 MRI studies.
“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 chief executive officer 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. We are very proud of the ClearPoint and Philips co-development team who have delivered another innovative product and further demonstrated our focus and commitment to being an innovative leader in neurosurgery.”
“Having spent more than 10 years developing the Maestro software inside of Philips and now here at ClearPoint, I know firsthand the capability and potential of this software inside the ClearPoint platform,” commented Lyubomir Zagorchev, vice president of Clinical Science and Applications at ClearPoint Neuro. “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. 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.”