ClearPoint Maestro Brain Model

by ClearPoint Neuro  · Based in United States → — Precise navigation to the brain and spine, enabling device, cell, and gene therapies.
Neurology Neurosurgery Radiology
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Regulatory Status Disclosed

Overview

The ClearPoint Maestro® Brain Model is an anatomical segmentation analysis tool developed in partnership with Philips. This AI-powered software automates the process of identifying, labeling, and quantifying the volume and shape of brain structures visible in MRI images. Its unique methodology combines deformable surfaces with active shape models and machine learning, resulting in accurate and highly reproducible segmentation. The Maestro Brain Model provides consistent, point-based correspondence for target identification, which is ideal for MRI-guided neuro interventions. Originally cleared as a standalone diagnostic platform, it has since been integrated into the ClearPoint Neuro Navigation System software (version 2.2 and later) to enhance surgical planning and execution.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated anatomical segmentation analysis of brain structures from MRI images
  • Identifies, labels, and quantifies brain structure volume and shape
  • Utilizes deformable surfaces, active shape models, and machine learning for segmentation
  • Offers superior segmentation reproducibility compared to manual methods and FreeSurfer
  • Provides consistent point-based correspondence for target identification
  • Facilitates patient-specific, multi-modal fusion for accurate target identification and trajectory planning
  • Enables fast, peri-procedural segmentation of cortical structures
  • Supports workflow for verifying brain structure segmentation results
  • Generates clinical procedure reports summarizing brain structure volume measurements
  • Integration with ClearPoint Neuro Navigation System software for enhanced functionality

Use Cases

  • MRI-guided neurosurgical interventions
  • Planning for cell and gene therapy delivery
  • Assisting in laser ablation procedures
  • Guidance for brain biopsies
  • Facilitating Deep Brain Stimulation (DBS) lead placement
  • Analysis and detection of subtle volumetric and shape abnormalities in traumatic brain injury (TBI)

What Physicians Need to Know

Brain MRI/CT Analysis
The ClearPoint Maestro Brain Model is an AI-enabled software designed for automatic labeling, visualization, volumetric, and shape quantification of segmentable brain structures from MRI images. It utilizes deformable surfaces, active shape models, and machine learning to provide highly reproducible results with sub-millimeter accuracy. The software automates the identification, labeling, and quantification of brain structure volume and shape. It includes subnuclei segmentation capabilities and has received FDA 510(k) clearance. The ClearPoint 2.2 software, which integrates the Maestro Brain Model, offers rapid automated segmentation for enhanced visualization in MRI-guided procedures, with ongoing work to extend subnuclei segmentation to CT scans for operating room use.
Neurodegenerative Disease Screening
While not explicitly a 'screening' tool, the Maestro Brain Model's ability to quantify and label the shape and volume of brain structures from MRI images, and provide point-based correspondence longitudinally and across patients, is relevant for monitoring subtle volumetric and shape abnormalities that may be associated with neurodegenerative diseases.
Physician Tip

The ClearPoint Maestro Brain Model offers precise anatomical segmentation and volumetric analysis, which is invaluable for neurosurgical planning and interventions. Physicians can leverage its sub-millimeter accuracy and capabilities for longitudinal comparison to perform patient-specific assessments, particularly for procedures such as deep brain stimulation (DBS), laser ablation, biopsy, and targeted drug/gene therapy delivery. Its integration with the ClearPoint Neuro Navigation System facilitates accurate target identification and trajectory planning in MRI-guided procedures.

The ClearPoint Maestro Brain Model is integrated into the ClearPoint Neuro Navigation System (ClearPoint 2.2 Software). It was developed in partnership with Royal Philips, with an ongoing collaboration to add fully automatic subnuclei segmentation. Additionally, ClearPoint Neuro has partnered with NE Scientific, LLC to integrate a GPU-accelerated software solution into the Maestro Brain Model for simulating patient-specific drug infusions, allowing for optimization of infusion parameters pre-procedure.

Details

Category Neurology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
DeploymentSoftware, available as a standalone diagnostic platform and integrated into the ClearPoint Neuro Navigation System software. Currently installed at select institutions in the United States.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The ClearPoint Maestro Brain Model received 510(k) clearance (K213645) on August 8, 2022. It is intended for automatic labeling, visualization, volumetric, and shape quantification of segmentable brain structures from a set of MRI images. It was cleared as a diagnostic platform for individuals with suspected traumatic brain injury (TBI) to quantify and label the shape and volume of brain structures from MRI images.
Integrations
EHR Not specified
Specialties Neurology, Neurosurgery, Radiology

What the Web Says

The ClearPoint Maestro Brain Model is an AI-enabled anatomical segmentation analysis tool developed by ClearPoint Neuro in partnership with Philips. It automates the identification, labeling, and quantification of brain structures from MRI images, aiming to improve accuracy and reproducibility in neurosurgical procedures. The software has received FDA clearance and is integrated into the ClearPoint Neuro Navigation System, which is used in over 60 clinical and research centers. It is designed to assist in various MRI-guided interventions, including deep brain stimulation, laser ablation, biopsy, and targeted drug delivery.

Overall: Positive

Strengths

  • Automated and highly reproducible segmentation of brain structures.
  • Superior performance compared to manual expert segmentation and other open-source software like FreeSurfer.
  • Enhances accuracy and efficiency in MRI-guided neuro interventions.
  • Facilitates precise target identification and trajectory planning for various procedures.
  • Supports advanced applications like quantifying drug delivery and simulating patient-specific infusions.
  • FDA cleared and integrated into an established navigation system.

Limitations

  • Requires a learning curve for procedural efficiency.
  • Routine MRI software updates can disrupt communication with the ClearPoint Neuro Navigation System.
  • Requires vigilance in MR distortion correction and IT maintenance.
  • Limited public reviews from individual physicians or healthcare IT professionals outside of company-sponsored information.
  • No specific reviews found on G2 or Capterra for the Maestro Brain Model itself, only for ClearPoint Strategy (a different product).
  • Reddit discussions are more about the company's stock and market opportunity rather than direct product reviews.

Based on reviews from: Birdeye, ClearPoint Neuro Official Communications/Publications, Diagnostic Imaging, NeuroImage (via ClearPoint Neuro and Diagnostic Imaging), Practical Neurology, accessdata.fda.gov, GlobeNewswire, M. V. Cunha's Substack, Indeed.com, PMC (PubMed Central), Umbrex Consulting, Reddit

Last updated: 2026-07-17

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Press & Coverage

GlobeNewswire
ClearPoint Neuro Announces FDA Clearance and First-in-Human Cases Performed with the New 2.2 Software Version and the Integrated Maestro Brain Model
ClearPoint Neuro announced FDA clearance and the first-in-human cases using its 2.2 Software with integrated Maestro Brain Modeling, alongside the publication of a validation study for the Maestro Brain Model in NeuroImage. The software offers rapid, peri-procedural segmentation of cortical brain structures to identify targets and safety zones for various neurosurgical procedures.
2024-02
Diagnostic Imaging
FDA Clears New Version of AI Segmentation Software for Brain MRI
The FDA granted 510(k) clearance for ClearPoint 2.2 software, an AI-enabled tool that provides automated segmentation of brain structures from MRI scans, enhancing visualization for targeted, MRI-guided procedures. The software includes the Maestro Brain Model, which has shown superior reproducibility compared to manual segmentation.
2024-02
ClearPoint Neuro, Inc.
ClearPoint Neuro to Showcase Two Novel Innovations at AANS 2023: ClearPoint Maestrou00ae Brain Model and ClearPoint Prismu2122 Neuro Laser Therapy System
ClearPoint Neuro announced it would exhibit at the 2023 AANS Annual Meeting, showcasing the ClearPoint Maestro Brain Model for the first time since its Limited Market Release. The Maestro Brain Model, which received FDA clearance in 2022, is designed for highly accurate MRI-guided interventions through patient-specific, multi-modal fusion for target identification and trajectory planning.
2023-04
BioPharma BoardRoom
ClearPoint Neuro extends agreement with Philips to include automatic subnuclei segmentation for DBS
ClearPoint Neuro expanded its worldwide license and research agreement with Philips to include subnuclei segmentation for MRI and potentially CT scans, aiming to enhance the ClearPoint Maestro Brain Model for accurate interventions in the operating room. The Maestro Brain Model, FDA cleared in 2022, uses a unique methodology combining deformable surfaces with active shape models and machine learning.
2023-04
ClearPoint Neuro, Inc.
ClearPoint Neuro Announces Agreement with NE Scientific to Integrate Gene Therapy Infusion Coverage Tool into ClearPoint Maestro Brain Model
ClearPoint Neuro announced an agreement with NE Scientific, LLC to integrate a gene therapy infusion coverage tool into the ClearPoint Maestro Brain Model. This collaboration aims to develop a GPU-accelerated software solution for modeling drug infusions delivered with the ClearPoint SmartFlow cannula.
2023-04
Medical Buyer
ClearPoint Neuro gets FDA nod for ClearPoint Maestro
US-based therapy-enabling platform company ClearPoint Neuro received 510(k) clearance from the FDA for its ClearPoint Maestro brain model. The Maestro brain model is a software tool designed to automate the process of identifying, labeling, and quantifying the volume and shape of brain structures visible in MRI images.
2022-08
MedImaging
AI Software Aids Anatomical Segmentation Analysis of Brain Structures in MRI Images
A new anatomical segmentation analysis tool, the ClearPoint Maestro Brain Model, has received 510(k) clearance, offering automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MRI images. Developed in partnership with Royal Philips, its unique methodology combines deformable surfaces with active shape models and machine learning.
2022-08
accessdata.fda.gov
ClearPoint Maestro Brain Model FDA 510(k) Clearance
The FDA 510(k) clearance document details the ClearPoint Maestro Brain Model, a standalone software application for automatic labeling, visualization, and quantification of segmentable brain structures from MRI images. The document highlights its substantial equivalence to predicate devices and its intended use in neurological procedures within the MRI environment.
2022-08

Videos

Product demos, reviews, and walkthroughs for ClearPoint Maestro Brain Model.

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Frequently Asked Questions

The ClearPoint Maestro Brain Model is an FDA-cleared software designed for automatic labeling, visualization, and volumetric quantification of brain structures from MRI images. It integrates with the ClearPoint Navigation System to provide stereotactic guidance for procedures such as deep brain stimulation, laser ablation, biopsy, and targeted drug or gene therapy delivery.
The ClearPoint Maestro Brain Model has received 510(k) clearance from the U.S. FDA. As an FDA-cleared medical device, it must adhere to stringent regulations regarding patient data handling and security, though specific data privacy protocols are not detailed in public releases.
The Maestro Brain Model has demonstrated highly reproducible results with sub-millimeter accuracy through cross-validation on over 1,000 MRI scans. Its methodology combines deformable surfaces with active shape models and machine learning to ensure reliable anatomical segmentation.
While highly accurate for anatomical segmentation, the current iteration primarily focuses on identification, labeling, visualization, and quantification of brain structures. Future developments aim to embed it more deeply into navigation for advanced patient-specific target identification and real-time simulation of drug delivery.
For brain segmentation, open-source alternatives like FreeSurfer exist, though studies indicate Maestro offers superior performance in accuracy and reproducibility. For surgical planning, other neuro-navigation systems are available, but Maestro's integration with the ClearPoint Navigation System offers a specialized, MRI-guided solution.
Specific pricing details for the ClearPoint Maestro Brain Model are not publicly disclosed in the provided information. Typically, medical device software pricing involves licensing fees, integration costs, and potentially per-procedure or subscription models, which would be discussed directly with ClearPoint Neuro.
ClearPoint Neuro plans to embed the Maestro Brain Model more deeply into its navigation software to enable advanced patient-specific target identification and trajectory planning. Future applications include quantifying drug delivery using intraoperative imaging and simulating patient-specific infusions in targeted brain regions.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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