ClearPoint System

by ClearPoint Neuro  · Based in United States →
Neurology Neurosurgery
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Regulatory Status Disclosed

Overview

The ClearPoint System by ClearPoint Neuro is a neuro-navigation platform designed to provide stereotactic guidance for neurological procedures. It is intended for use by neurosurgeons in operating room environments, integrating with both MR and CT imaging. The system facilitates procedures such as biopsies, catheter and electrode insertions, including deep brain stimulation (DBS) lead placement, and the delivery of therapeutics to the brain.

The ClearPoint System fits into a clinical workflow by offering surgical planning, navigation to the target, and device delivery. It supports both MRI-guided and iCT-guided workflows, allowing for intraprocedural adjustments and real-time visualization. The system’s software provides functionality for automatic identification, labeling, visualization, and quantification of segmentable brain structures from loaded images. Notable capabilities include real-time visualization via MRI guidance for hemorrhage detection and precise placement during biopsies, and the ability to refine trajectories intra-procedurally. The SmartFrame Array, an accessory, is designed to streamline multi-trajectory procedures for drug delivery, laser catheter insertion, and biopsies. The system is compatible with 1.5T and 3T MRI scanners.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

What Physicians Need to Know

Brain MRI/CT Analysis
The ClearPoint System, particularly with its 2.2 software and Maestro Brain Model, utilizes AI for automated segmentation of brain structures from MRI scans. This capability provides rapid, peri-procedural segmentation of cortical structures to identify targets and safety zones for procedures such as cell and gene therapy delivery, laser ablation, biopsy, and deep brain stimulation. The system also supports guidance using CT imaging.
Physician Tip

Leverage the AI-enabled automated brain segmentation for enhanced precision in surgical planning and real-time intraoperative guidance. This feature is crucial for accurately identifying neurological targets and critical safety zones during complex procedures like deep brain stimulation, laser ablation, and targeted drug delivery, potentially improving procedural efficiency and patient outcomes. The integration of the Maestro Brain Model offers superior reproducibility in segmentation compared to manual methods, aiding consistent target identification for MRI-guided neuro interventions.

The ClearPoint System is designed as an integral part of neurosurgical workflows, integrating with MR and CT imaging for real-time guidance and planning. While it provides advanced image analysis for surgical navigation, it is not presented as a diagnostic AI platform for stroke detection, EEG interpretation, seizure detection, or neurodegenerative disease screening. Its primary integration is within the neurosurgical suite, enabling precise delivery of therapies and devices.

Details

Category Neurology AI, Surgical AI
Pricing Unknown
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Neurology, Neurosurgery

What the Web Says

The ClearPoint System, particularly the ClearPoint Neuro Navigation System, is a highly-regarded technology in neurosurgery, enabling real-time MRI-guided procedures for deep brain stimulation, laser ablation, biopsies, and drug delivery. It is praised by physicians for its accuracy, safety, and ability to enhance surgical precision. The ClearPoint Strategy software, a separate but related product for strategic planning, is also well-received for its intuitive interface, comprehensive features, and excellent customer support, though some users note a learning curve for advanced functionalities.

Overall: Mixed

Strengths

  • Real-time MRI guidance for enhanced accuracy and safety in neurosurgery procedures.
  • Minimally invasive approach, leading to improved patient comfort and reduced recovery times.
  • Supports a wide range of neurosurgical applications, including DBS, laser ablation, biopsies, and targeted drug delivery.
  • Intuitive and user-friendly software interface for surgical planning and navigation.
  • Exceptional customer support and responsive team.
  • Efficient reporting and strategic planning capabilities with AI features.

Limitations

  • Steep learning curve for new users, especially with advanced features and initial setup.
  • Limited customization options for report visuals in the strategic planning software.
  • Potential for disruption in communication between MRI and the navigation system due to routine MRI software updates.
  • The company (ClearPoint Neuro Inc.) has not yet achieved profitability, with negative EPS and free cash flow.
  • Some users find the interface not intuitive, requiring a learning curve for effective navigation and usage.
  • Risk that the drug delivery side of the business may not receive FDA approvals in a timely manner or at all.

Based on reviews from: G2, Capterra, Reddit, Birdeye, Software Finder, PubMed, Stock Titan, DirectorsTalk Interviews, RWJBarnabas Health, ClearPoint Neuro

Last updated: 2026-07-18

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Press & Coverage

ClearPoint Neuro, Inc.
ClearPoint Neuro Enters into 10-year Focused Ultrasound Development Partnership with Sungkyunkwan University, South Korea, Further Expanding Our Drug Delivery Ecosystem and Global Footprint
ClearPoint Neuro announced a 10-year focused ultrasound development partnership with Sungkyunkwan University in South Korea, aiming to expand its drug delivery ecosystem and global presence.
2026-05
ClearPoint Neuro, Inc.
ClearPoint Neuro Reports First Quarter 2026 Results
ClearPoint Neuro released its first-quarter 2026 financial results, providing an update on the company's performance and financial standing.
2026-05
ClearPoint Neuro, Inc.
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 received FDA clearance for its 2.2 software version with the integrated Maestro Brain Model, which offers fast, peri-procedural segmentation of cortical brain structures.
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 for automated segmentation of brain structures from MRI scans, enhancing visualization for targeted procedures.
2024-02
Aspen Neuroscience
Parkinson's Disease Clinical Trial Uses Intraoperative MRI to Guide Precision Implantation of Patients' Own Autologous Replacement Neurons
Aspen Neuroscience is utilizing the MRI-guided ClearPoint Navigation System in its ASPIRO Phase 1/2a clinical trial for Parkinson's disease, enabling precise transplantation of dopaminergic neuron precursor cells.
2024-06
ResearchGate (World Neurosurgery)
The ClearPoint Array Frame: An MRI Compatible System that Supports Non-craniotomy, Multi-trajectory (NCMT) Stereotactic Procedures
This study reports initial safety and user experience data for the ClearPoint SmartFrame Arrayu00ae system, an MRI-compatible frame with customized neuro-navigation software, cleared by the FDA in January 2021.
2024-02
ClearPoint Neuro, Inc.
ClearPoint Neuro Announces Full Market Release of ClearPoint Navigation Software Version 3.0 u2013 Delivering the First End-to-End ClearPoint Navigation Solution to the Operating Room
ClearPoint Neuro announced the full market release of its Navigation Software Version 3.0, which introduces an iCT image-guidance workflow option for traditional operating rooms.
2025-04
Karger Publishers (Stereotactic and Functional Neurosurgery)
Stereotactic Accuracy and Technique Utilizing the SmartFrame OR Platform with Stereotactic Navigation and Cone Beam CT Image-Guided Forward Projection
This study analyzed the accuracy and efficiency of the ClearPoint SmartFrame ORu2122 system for DBS electrode placement, demonstrating submillimeter accuracy comparable to MRI-guided platforms while eliminating MRI dependency.
2025-12

Videos

Product demos, reviews, and walkthroughs for ClearPoint System.

View all on YouTube

Frequently Asked Questions

The ClearPoint System's AI-enabled software, such as ClearPoint 2.2, provides automated segmentation of brain structures from MRI scans, facilitating rapid and precise identification of targets and safety zones for procedures like deep brain stimulation, laser ablation, and cell/gene therapy delivery. This real-time MRI guidance allows neurosurgeons to visualize instruments and patient anatomy simultaneously, enabling accurate trajectory adjustments and potentially reducing procedure time and risks.
The AI-enabled ClearPoint 2.2 software has received 510(k) clearance from the FDA for automated segmentation of brain structures, and the ClearPoint Neuro Navigation System itself is FDA cleared and CE-marked. While specific data privacy details for the neuro navigation system were not explicitly detailed in the search results, medical devices are subject to strict regulations like HIPAA, and the system is designed to integrate with existing hospital infrastructure, which would typically have its own data security protocols.
Alternatives in stereotactic neuro-navigation include systems from companies like Brainlab, Renishaw, Globus Medical, and Zeta Surgical. ClearPoint Neuro uniquely specializes in MRI-guided neurosurgical tools, offering continuous intraprocedural MRI guidance for real-time visualization and adjustment, which is a key differentiator, especially for complex procedures like cell and gene therapy infusions. Its AI-enabled segmentation further streamlines planning and target identification.
ClearPoint Neuro's pricing is not publicly disclosed and is often customized based on factors such as the number of users, support level, and required integrations. The system aims to enhance revenue potential for physicians and hospitals by potentially reducing procedure times and enabling treatment for more patients. Reimbursement for procedures using the ClearPoint System is based on medical necessity and specific CPT, ICD-10, and DRG codes, with support available for navigating these complexities.
While the ClearPoint System offers significant benefits, there can be a learning curve for procedural efficiency, with studies suggesting approximately four cases are needed to achieve proficiency. The system's use in an MRI environment is currently limited to 1.5 and 3.0 Tesla MRI scanners. Additionally, ongoing vigilance regarding MR distortion correction and IT maintenance is crucial for optimal performance.

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Contact for pricing

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