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ClearPoint Neuro

Solana Beach, CaliforniaFounded 1998

ClearPoint Neuro is a global therapy-enabling platform focused on navigation and delivery to the brain. Its mission is to help guide therapies when the path is unclear.

FDA devices
1
Founded
1998
Employees
101–250

reccy insights

Recent highlights

ClearPoint Neuro expanded its regulatory reach and product activity across 2025 and 2026. On January 22, 2026, it announced EU MDR certification and CE Mark for ClearPoint Navigation Software Version 3.0.2, including intraoperative CT workflows. On April 20, the company announced Canadian authorization for its Navigation System. A separate April 22 announcement covered FDA clearance of the Velocity Alpha MR High Speed Surgical Drill System, developed with adeor medical for integration with the SmartFrame platform. On May 27, ClearPoint entered a 10-year development partnership with Sungkyunkwan University’s SONOCARELAB to develop focused-ultrasound hardware with its navigation software and planned robotic system for brain drug delivery. Dr. Paul Larson’s appointment as Chief Medical Officer took effect in January 2026. The company also reported second-quarter 2026 revenue of $10.9 million, up 18% year over year, while reducing its 2026 revenue outlook to $48–$52 million from $52–$56 million. These milestones show continued product and geographic expansion alongside a more cautious near-term revenue outlook.

Written by reccy's AI from company sites, press and funding records · updated Oct 2026

What makes ClearPoint Neuro distinct

  1. 01Combines image-guided brain navigation with delivery of devices and therapies to targeted brain regions.
  2. 02Supports MRI- and CT-guided neurosurgical workflows, including intraoperative CT.
  3. 03Offers an operating-room navigation platform designed to support optical workflows without requiring MRI guidance.
  4. 04Product range spans navigation, cannula-based delivery, laser therapy, and intracranial fluid management.
  5. 05Developing applications for drug, biologic, cell, and gene therapy delivery to the brain.

Technology & products6

  • ClearPoint Neuro Navigation System

    Image-guided stereotactic navigation platform for planning and guiding neurological procedures, including biopsy, electrode and catheter placement, laser catheter placement, and therapeutic delivery.

  • ClearPoint Navigation System Software

    Software for surgical planning, anatomical visualization, stereotactic navigation, and device delivery during MRI- or CT-guided neurological procedures.

  • ClearPoint Prism Neuro Laser Therapy System

    Navigation-enabled system for positioning laser catheters in targeted brain structures during minimally invasive laser therapy.

FDA regulatory

  • De Novo· Class II
    SmartFlow Neuro Cannula

    Brain Intraparenchymal Infusion Cannula · DEN240023 · product code SDG

    Granted Nov 13, 2024

Recent updates9

  • May 27, 2026Partnership

    ClearPoint Neuro entered a 10-year development partnership with Sungkyunkwan University’s SONOCARELAB to co-develop focused-ultrasound hardware integrated with ClearPoint navigation software and a planned robotic system for blood-brain barrier drug delivery and related neurological applications.

    pharmiweb.com
  • Apr 22, 2026Partnership

    ClearPoint Neuro and adeor medical collaborated on the Velocity Alpha MR High Speed Surgical Drill System, with adeor manufacturing the drill for integration into ClearPoint’s SmartFrame neurosurgical platform.

    pharmiweb.com
  • Apr 20, 2026Product launch

    ClearPoint Neuro received a Health Canada Medical Device License for its Navigation System, extending MRI and iCT guidance workflows to Canadian neurosurgery centers.

    pharmiweb.com

About ClearPoint Neuro

Products
ClearPoint Neuro Navigation System, ClearPoint Navigation System Software, ClearPoint Prism Neuro Laser Therapy System, IRRAflow Active Fluid Exchange System, SmartFlow Cannula, SmartFrame OR Platform
Leadership
Joseph Burnett, President and CEOChris Yelley, Vice President, OperationsWendelin Maners, Vice President, MarketingMary McNamara-Cullinane, Vice President of Regulatory Affairs
Focus areas
Neurotechnology, medical devices, digital health, therapeutics, research tools, biotechnology, health care, brain navigation
Headquarters
Solana Beach, California
Founded
1998
Employees
101–250