FDA Clears AI-Enabled Software for Streamlining Brain MRI Assessment and Reporting

Offering the promise of more efficient reporting of findings from magnetic resonance imaging (MRI) of the brain, the Maestro Brain Model has garnered 510(k) clearance from the Food and Drug Administration (FDA), according to the software’s manufacturer ClearPoint Neuro.

Combining deformable surfaces with active shape models and machine learning, the Maestro Brain Model can provide neuroradiologists with automated labeling as well as shape and volumetric quantification of brain structures on MRI scans.

ClearPoint Neuro said the anatomical segment analysis tool emerged from research examining volumetric and shape abnormalities caused by mild traumatic brain injuries. Noting cross-validation of the technology with more than 1,000 MRI scans, the company noted the Maestro Brain Model offers accurate and highly reproducible results.

The company says future applications of the Maestro Brain Model may facilitate targeted treatment of brain injuries

“Our plan is to quantify drug delivery using intraoperative imaging and simulate patient-specific infusions in targeted brain regions,” explained Lyubomir Zagorchev, a vice-president of Clinical Science and Applications at ClearPoint Neuro. “The unique shape representation in (the Maestro Brain Model) 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.”