ClearPoint Neuro

120 S. Sierra Ave. Suite 100, Solana Beach, CA 92075, USA All United States companies → — Founded 1998

Medical Device / Hardware Specialty-Focused AI

Neurology Neurosurgery Radiology

Neurology AI Radiology & Imaging AI Surgical AI

Publicly Held — $181.7M

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Products

ClearPoint Maestro Brain Model

ClearPoint Neuro

Neurology AI

The ClearPoint Maestro Brain Model is an FDA-cleared AI-powered software for automatic, highly reproducible anatomical brain segmentation from MRI images, crucial for precise neurosurgical planning and interventions.

Contact for pricing

ClearPoint System

ClearPoint Neuro

Neurology AI

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 […]

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About ClearPoint Neuro

ClearPoint Neuro is a global therapy-enabling platform company specializing in precise navigation for procedures in the brain and spine. The company offers an integrated system designed for minimally invasive neurosurgical interventions, providing both established clinical products and pre-clinical development services for controlled drug and device delivery. Its flagship product, the ClearPoint Neuro Navigation System, holds FDA clearance and is CE-marked, facilitating applications such as electrode insertion, placement of laser catheters, biopsy, and the delivery of approved therapeutics within the brain.

For physicians, ClearPoint Neuro’s technology is crucial for addressing complex neurological disorders with pinpoint accuracy and precision. The company’s offerings extend to supporting clinical trials for the delivery of biologics, gene, and stem cell therapies to the brain. A key innovation is their AI-enabled ClearPoint 2.2 software, which provides rapid, automated segmentation of brain structures from MRI scans. This software significantly enhances visualization and planning for targeted, MRI-guided procedures, including deep brain stimulation, laser ablation, biopsy, and the delivery of cell and gene therapies.

ClearPoint Neuro is actively engaged with healthcare and research centers across North America, Europe, Asia, and South America, and collaborates with over 60 active biopharma partners on cell and gene therapy delivery solutions. Their comprehensive ecosystem includes pre-planning software, peri-procedural neuro navigation hardware, cannula-based routes of administration, AI-informed quality control documentation, and expert clinical support.

Focus Areas

Neurosurgical navigation MRI-guided procedures deep brain stimulation (DBS) laser ablation biopsy drug delivery (biologics gene therapy stem cell therapies) neuro-aspiration intraoperative CT workflow anatomical segment analysis (using machine learning)

Business Intelligence

Key Investors	Oberland Capital Management LLC, PTC Therapeutics, BlackRock, Inc., Vanguard Group Inc, Geode Capital Management, Llc, State Street Corp, Millennium Management Llc, StemPoint Capital LP, FirstWave Capital Management LLC, Lane Generational LLC, UBS Group AG, Brown Advisory Inc.
Partnerships	Koninklijke Philips N.V., UCB Biopharma SRL, Clinical Laserthermia Systems AB (CLS), University of California, San Francisco (UCSF), NE Scientific, LLC, over 50 biologics/pharmaceutical companies, academic centers, and contract research organizations
Acquisitions	IRRAS (completed November 2025)
Technology	ClearPoint Neuro Navigation System (hardware, software, disposables), ClearPoint Prism Neuro laser therapy system, SmartFlow Neuro Cannula, IRRAflow system, ClearPoint Array Platform, ClearPoint Maestro Brain Model (utilizes machine learning for anatomical segment analysis). The platform supports real-time MRI and intraoperative CT guidance.
FDA Clearances	6 cleared products (estimated)

What Physicians Need to Know

Neurosurgical Navigation & MRI-Guided Procedures

ClearPoint Neuro's core platform provides real-time MRI guidance for stereotactic neurosurgical procedures, enabling precise planning, trajectory refinement, and device placement. This system is FDA-cleared and CE-marked, supporting a wide range of interventions within the MRI suite or integrated MR/OR configurations.

Deep Brain Stimulation (DBS)

Specializes in MRI-guided lead placement for Deep Brain Stimulation (DBS) and Responsive Neurostimulation (RNS). A key differentiator is the ability to perform DBS procedures under general anesthesia, offering consistent and effective electrode placement with high-resolution imaging.

Laser Ablation (LITT)

Features the ClearPoint Prismu00ae Neuro Laser Therapy System for MRI-guided laser interstitial thermal therapy (LITT). This system is designed for precise coagulation of soft tissue, particularly in hard-to-reach areas, and offers workflow efficiencies with next-generation non-cooled laser applicator technology.

Biopsy

Empowers MRI-guided brain biopsy procedures with real-time visualization, allowing neurosurgeons to confirm the biopsy site, detect hemorrhage promptly, and perform additional biopsies intra-procedurally to secure a definitive diagnosis.

Drug Delivery (Biologics, Gene & Stem Cell Therapies)

Offers advanced solutions for direct central nervous system delivery of therapeutics, including biologics, gene, and stem cell therapies. The SmartFlowu00ae Cannula utilizes Convection Enhanced Delivery (CED) to bypass the blood-brain barrier, enabling real-time monitoring of infusate coverage and intraprocedural adjustments. It is the first device commercially approved in the US and Europe for gene therapy delivery to the brain parenchyma.

Neuro-aspiration

Provides the ClearPoint PURSUITu2122 Neuro Aspiration System for controlled aspiration of blood, clotted blood, cystic components of tumors, abscesses, colloid cysts, and cerebral spinal fluid under real-time MRI guidance.

Anatomical Segment Analysis (AI/ML)

Leverages the ClearPoint Maestrou00ae Brain Model and ClearPoint 2.2 Software, an AI-enabled tool developed with Philips, for automated identification, labeling, visualization, and quantification of brain structures from MRI images. This technology combines deformable surfaces with active shape models and machine learning for highly accurate and reproducible segmentation, aiding target identification and safety zone definition.

Key Differentiators

ClearPoint Neuro stands out with its real-time MRI guidance for unparalleled precision and safety, enabling intra-procedural adjustments and immediate hemorrhage detection. Their 'One Procedure, One Room' approach minimizes patient transport and infection risk. The SmartFlowu00ae Cannula's Convection Enhanced Delivery (CED) is unique for effective drug distribution, and their AI-powered Maestro Brain Model offers superior anatomical segmentation. The company is a leading platform for CNS-targeted cell and gene therapies, offering comprehensive preclinical and clinical trial support, including patient-specific infusion modeling.

Technology Stack

The core is the FDA-cleared and CE-marked ClearPoint Neuro Navigation System. Key components include the SmartFlowu00ae Cannula for drug delivery, the ClearPoint Prismu00ae Neuro Laser Therapy System for LITT, the ClearPoint Maestrou00ae Brain Model and 2.2 Software for AI-driven anatomical segmentation, the SmartFrame Arrayu00ae for multi-trajectory procedures, and the SmartFrame ORu2122 platform for OR-based DBS. They also offer the ClearPoint PURSUITu2122 Neuro Aspiration System and are developing GPU-accelerated software for 4D drug infusion modeling. The system is compatible with 1.5T and 3T MRI scanners and supports both MR and CT imaging for planning and operation.

Physician Tip

For physicians, ClearPoint Neuro offers enhanced precision and accuracy through real-time MRI guidance and AI-powered anatomical analysis, leading to improved patient safety with immediate hemorrhage detection and reduced procedural risks. The platform expands treatment options, allowing complex procedures like DBS under general anesthesia and enabling the delivery of cutting-edge gene and cell therapies. Expect streamlined workflows, reduced patient anxiety, and data-driven decision-making with real-time visualization and infusion monitoring. Their comprehensive support for clinical trials and translational research also positions them as a valuable partner for advancing novel neurological treatments.

ClearPoint Neuro's systems are designed for broad compatibility, integrating with major 1.5T and 3T MRI scanners. They have strategic partnerships, including with Philips for the Maestro Brain Model and NE Scientific for advanced drug infusion modeling. The platform supports both MRI and CT imaging for planning and operation, and offers compatibility with surgical navigation system probes and trackers to facilitate seamless OR-to-MR workflows.

At a glance

Founded 1998

HQ 120 S. Sierra Ave. Suite 100, Solana Beach, CA 92075, USA · United States

Team size 172

CEO Joseph M. Burnett

Funding Publicly Held — $181.7M

FDA clearances 6 (estimated)

Products 2

Products by ClearPoint Neuro

2 products in the directory

ClearPoint Maestro Brain Model

ClearPoint Neuro

Neurology AI

Contact for pricing

ClearPoint System

ClearPoint Neuro

Neurology AI

What the Web Says

ClearPoint Neuro develops medical devices and software for precise neurosurgical procedures, including deep brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs and gene therapy to the brain. Their ClearPoint Neuro Navigation System is FDA-cleared and CE-marked, installed in over 60 clinical and research centers globally. The company is also involved in strategic partnerships with biopharma companies for CNS therapy delivery. Employer reviews suggest a generally positive work environment with good leadership and work-life balance, although some mention a lack of organization.

Overall: Mixed

Strengths

Products enable minimally invasive and highly accurate neurosurgical procedures.
Strong potential in gene therapy and drug delivery to the brain.
Good leadership and work environment reported by employees.
Positive work-life balance.
Company has a bright future and is expanding.
Excellent customer support for their strategic planning software (ClearPoint Strategy).

Limitations

Some employer reviews mention a lack of organization.
Concerns about share dilution and warrants have been raised on Reddit.
Uncertainty regarding FDA approval for rare disease therapies.
Steep learning curve for their strategic planning software (ClearPoint Strategy).
Limited customization options in report visuals for ClearPoint Strategy.
Price of ClearPoint Strategy can be high for some organizations.

Based on reviews from: Birdeye, Indeed.com, Reddit, BioSpace, Stock Titan, Capterra, G2, Umbrex Consulting, Pluang

Last updated: 2026-07-18

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Press & Coverage

ClearPoint Neuro, Inc. (Press Release)

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 partnership with Sungkyunkwan University to develop focused ultrasound solutions, aiming to expand its drug delivery ecosystem for cell, gene, and biologic therapies. This collaboration supports ClearPoint Neuro's entry into the focused ultrasound market and its strategy to broaden its neurosurgical and drug delivery offerings globally.

2026-05

ClearPoint Neuro, Inc. (Press Release)

ClearPoint Neuro Announces CE Marking of Velocity Alpha MR High Speed Surgical Drill System, Further Expanding Drug Delivery Ecosystem and Global Footprint

ClearPoint Neuro received CE Marking for its Velocity Alpha MR High Speed Surgical Drill System, which had previously received FDA 510(k) clearance in the United States. This approval in Europe is expected to enhance procedural workflows and strengthen ClearPoint Neuro's ecosystem globally.

2026-05

BioSpace

ClearPoint Neuro Announces FDA Clearance of the Velocity Alpha(R) MR High Speed Surgical Drill System and First Clinical Use, Further Expanding Our Drug Delivery Ecosystem and Global Footprint

ClearPoint Neuro announced FDA 510(k) clearance and the first clinical use of its Velocity Alpha MR High Speed Surgical Drill System, designed to streamline procedures and improve efficiency in both MR and operating room environments. This new drill system is purpose-built to integrate with ClearPoint Neuro's SmartFrame navigation platform.

2026-04

ClearPoint Neuro, Inc. (Press Release)

ClearPoint Neuro Announces Canadian Approval for its Navigation System Further Expanding Our Drug Delivery Ecosystem and Global Footprint

ClearPoint Neuro received a Medical Device License from Health Canada for its Neuro Navigation System, expanding its drug delivery ecosystem and global footprint to include both MRI-guidance and new iCT-guidance workflows in Canada. This approval builds on a previous therapy delivery product clearance for the SmartFlow Neuro Cannula.

2026-04

ClearPoint Neuro, Inc. (Press Release)

ClearPoint Neuro Announces EU MDR Certification for ClearPoint Navigation Software Version 3.0.2, Expanding Access to the Latest Operating Room Navigation Platform in Europe

ClearPoint Neuro announced it has received EU MDR Certification for its ClearPoint Navigation Software Version 3.0.2, unifying its global navigation platform and expanding access to its latest operating room navigation technology in Europe. This certification is expected to enable consistent training and hospital IT support across regions.

2026-01

ClearPoint Neuro, Inc. (Press Release)

ClearPoint Neuro Announces Expanded International Clearances for Key Therapy Delivery Product; Now Totaling 34 Countries Worldwide

ClearPoint Neuro announced expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan, bringing the total number of countries where its therapy delivery product is cleared to 34. These clearances are intended to simplify clinical trial design and provide partners with expanded pathways for global commercialization.

2025-10

Investing.com UK

ClearPoint Neuro secures up to $105 million financing

ClearPoint Neuro announced a financing agreement with Oberland Capital Management LLC for up to $105 million, with an initial $30 million funded at closing. This financing includes options for additional funds and a purchase of ClearPoint Neuro common stock by Oberland Capital.

2025-05

ClearPoint Neuro, Inc. (Press Release)

Journal of Neurosurgery Publication Demonstrates Distinct Advantages of ClearPoint Prismu00ae Neuro Laser Therapy System

Preclinical results of an in vivo validation study for the ClearPoint Prism Neuro Laser Therapy System were published in the Journal of Neurosurgery, demonstrating its accuracy in real-time temperature monitoring of brain tissue. The study highlighted the system's potential for treating intractable epilepsy, movement disorders, and brain tumors.

2024-03

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