Welcome to our dedicated page for Clearpoint Neuro news (Ticker: CLPT), a resource for investors and traders seeking the latest updates and insights on Clearpoint Neuro stock.
ClearPoint Neuro, Inc. develops and commercializes medical-device and therapy-enabling systems for precise navigation to the brain and spine. Its recurring news includes updates on the FDA-cleared and CE-marked ClearPoint Neuro Navigation System, SmartFrame navigation platform, SmartFlow Neuro Cannula, Velocity Alpha MR High Speed Surgical Drill System, and services that support controlled CNS delivery for cell and gene therapy programs.
Company announcements also cover financial results, product clearances and international regulatory approvals, preclinical development services, biopharma and academic partnerships, and integration of the completed IRRAS Holdings acquisition, which expanded the portfolio into neurocritical care and IRRAflow-related products.
ClearPoint Neuro (Nasdaq: CLPT) reported first quarter 2026 revenue of $12.1 million, up 43% year over year, with 16% organic growth and 25% organic device growth. Neurosurgery navigation revenue rose 80% and capital equipment 177%. Gross margin improved to 64%, and cash totaled $35.6 million. 2026 revenue is estimated at $52–56 million.
ClearPoint Neuro (NASDAQ:CLPT) announced that its Velocity Alpha MR High Speed Surgical Drill System has received CE Marking, adding to existing FDA 510(k) clearance in the US.
The Adeor Medical–manufactured drill integrates with ClearPoint’s SmartFrame platform to support multi-trajectory neurosurgical, cell, and gene therapy procedures and broaden the company’s global drug delivery ecosystem.
ClearPoint Neuro (NASDAQ:CLPT) will release first-quarter 2026 financial results on Wednesday, May 13, 2026, after the market close. A live broadcast and conference call will begin at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
Listeners can join via webcast or telephone; a replay will be available through June 12, 2026, and an online archive will be posted on the company's investor website.
ClearPoint Neuro (NASDAQ:CLPT) announced FDA 510(k) clearance of the Velocity Alpha MR High Speed Surgical Drill and reported the system's first clinical use on April 22, 2026 in a four-trajectory procedure. The drill integrates with ClearPoint's SmartFrame navigation and is manufactured by adeor medical AG.
The device is designed for multi-trajectory, MR and OR workflows, aims to streamline procedures, and is expected to be compatible with ClearPoint's robotic navigation platform now in development.
ClearPoint Neuro (NASDAQ:CLPT) received a Medical Device License from Health Canada on April 20, 2026 for its Neuro Navigation System, covering both MRI-guidance and new iCT-guidance workflows in Canada.
This clearance, which follows the SmartFlow Neuro Cannula delivery clearance in October 2025, allows biopharma partners to run Canadian clinical trial and commercial sites using ClearPoint's integrated navigation and therapy-delivery platform and supports the company's strategy to enable 20,000 cell and gene therapy procedures annually.
ClearPoint Neuro (Nasdaq:CLPT) reported record 2025 results with $37.0M revenue, 18% growth, and Q4 revenue of $10.4M (34% growth). The company completed the November 2025 acquisition of IRRAS, secured $20.0M additional financing access, achieved EU MDR certification, and ended 2025 with $45.9M cash.
Management projects 2026 revenue of $52.0–$56.0M and highlighted product, commercial, and cell/gene therapy expansion initiatives.
ClearPoint Neuro (NASDAQ: CLPT) will release its fourth quarter and full year 2025 financial results on March 17, 2026 after market close. A live broadcast and teleconference for investors and analysts is scheduled for 4:30 p.m. ET / 1:30 p.m. PT.
A replay will be available through April 16, 2026, and an online archive will be posted on the company's investor website.
ClearPoint Neuro (NASDAQ:CLPT) announced EU MDR certification (CE mark) for ClearPoint Navigation Software Version 3.0.2, making the release available in Europe and unifying the US and EU navigation platforms.
Version 3.0.2 adds an intraoperative CT workflow and compatibility with intraoperative CT and cone-beam CT, extending navigation from MRI-only to operating room use when paired with the SmartFrame XG stereotactic frame. The company cited prior FDA clearance of ClearPoint 3.x 11 months earlier and said most US customers have adopted the software.
ClearPoint Neuro (Nasdaq:CLPT) reported preliminary unaudited Q4 2025 revenue of ~$10.4M, representing 20% comparable sales growth versus Q4 2024; IRRAflow product sales were only partially included after a recent acquisition. Full-year 2025 revenue was approximately $37M. Management expects 2026 total revenues of $54M–$60M, driven by organic growth and completion of IRRAflow integration. Segment trends in Q4 included functional neurosurgery disposables (+23%) and biologics/drug delivery (+26%). Results are preliminary and unaudited; audited financials and a Form 10-K will be filed in Q1 2026. Management will meet investors at the J.P. Morgan Healthcare Conference on January 12–13, 2026.
ClearPoint Neuro (Nasdaq:CLPT) completed its acquisition of IRRAS on November 20, 2025. Consideration included $5.0 million cash and 1,325,000 shares of ClearPoint common stock, plus a revenue share on certain IRRAS products for defined periods. IRRAS brings the IRRAflow active fluid-exchange system, more than 50 active customers, and an expanded commercial team. IRRAS results will be consolidated into ClearPoint's financials starting in Q4 2025. Management highlighted expected commercial scale and strategic fit with ClearPoint’s neuro drug-delivery platform.