CLPT Gets EU MDR Certification for ClearPoint Navigation Software

ClearPoint secures EU MDR certification for ClearPoint Navigation Software 3.0.2, expanding precision-guided surgery access across MRI suites and operating rooms.

Zacks Investment Research • Jan 27, 2026

ClearPoint Neuro: From Validation To Scale

ClearPoint Neuro is positioned for robust growth in 2026, driven by IRRAS, the PRISM 1.5T system clearance, and the company's new CRO facility. While the immediate future of uniQure's AMT-130 remains unknown, ClearPoint has a large number of drug delivery partners that continue to generate strong data. CLPT's valuation is modest given the company's solid competitive positioning and the step change in revenue that will occur when programs in areas like Parkinson's and epilepsy are commercialized.

Seeking Alpha • Jan 27, 2026

ClearPoint Neuro Gets EU Green Light For Updated Brain Surgery Software

ClearPoint Neuro, Inc. (NASDAQ: CLPT) on Friday said it received EU MDR Certification for its ClearPoint Navigation Software Version 3.0.2.

Benzinga • Jan 23, 2026

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

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / January 22, 2026 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received EU MDR Certification for its ClearPoint Navigation Software Version 3.0.2. "By achieving CE Mark for the ClearPoint Navigation 3.0.2 software, we are able to unify our global navigation platform which we believe will enable consistent training and hospital IT support," commented Mazin Sabra, Chief Operating Officer at ClearPoint Neuro.

Accesswire • Jan 22, 2026

ClearPoint Neuro Announces Preliminary Unaudited Fourth Quarter and Full Year 2025 Revenue

The Company Achieved 20% Comparable Sales Growth in the Fourth Quarter of 2025 at $10.4 Million SOLANA BEACH, CALIFORNIA / ACCESS Newswire / January 12, 2026 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced preliminary unaudited revenue growth for its fourth quarter of 2025. These preliminary unaudited financial results are management's estimates, are subject to revision in the course of completing annual audit processes, and do not represent a comprehensive statement of the Company's financial results for the period.

Accesswire • Jan 12, 2026

Investment strategist names 10 sub-$10 billion stocks to watch in 2026

Investment strategist Shay Boloor has outlined ten sub-$10 billion market-cap companies he believes are positioned to benefit from powerful long-term trends heading into 2026.

Finbold • Dec 13, 2025

ClearPoint Neuro Completes Acquisition of IRRAS

Acquisition Will Enhance ClearPoint Neuro's Commercial Scale, Drive Operational Leverage, and Support Its Long-Term Strategy in CNS Drug Delivery Innovation SOLANA BEACH, CALIFORNIA / ACCESS Newswire / November 20, 2025 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that it has completed its previously announced acquisition of IRRAS Holdings, Inc. ("IRRAS"). The transaction closed on November 20, 2025 following receipt of IRRAS shareholder approval and satisfaction or waiver of all required closing conditions.

Accesswire • Nov 20, 2025

ClearPoint Neuro, Inc. (CLPT) Q3 2025 Earnings Call Transcript

ClearPoint Neuro, Inc. ( CLPT ) Q3 2025 Earnings Call November 6, 2025 5:00 PM EST Company Participants Joseph Burnett - President, CEO & Director Danilo D'Alessandro - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets, LLC, Research Division Presentation Operator [Audio Gap] comments made on this call may include statements that are forward-looking within the meaning of securities laws. These forward-looking statements may include, without limitation, statements related to anticipated industry trends, the company's plans, prospects and strategies, both preliminary and projected, the size of total addressable markets or the market opportunity for the company's products and services, the company's expectation for future development, regulatory approval, timing, commercialization and the market for cell and gene therapies and the anticipated adoption of the company's products and services for use in the delivery of gene and cell therapies, and management's expectations, beliefs, estimates or projections regarding future revenue and results of operations.

Seeking Alpha • Nov 12, 2025

ClearPoint Neuro: CRO Facility Should Reaccelerate Growth

ClearPoint's third quarter results were weak, which was at least partly due to resource constraints while its new CRO facility was being opened. The near-term outlook for ClearPoint's biopharma business is also now clouded by FDA uncertainty around uniQure's AMT-130. The new CRO facility, PRISM 1.5T clearance, and IRRAS acquisition set ClearPoint up for much stronger growth going forward.

Seeking Alpha • Nov 12, 2025

ClearPoint Neuro Announces Agreement to Acquire IRRAS

Acquisition Will Further Expand the Potential of ClearPoint Neuro's Drug Delivery Portfolio While Immediately Adding New Indications and Commercial Scale Across a $0.5 Billion Market for the Treatment of Intracranial Bleeding SOLANA BEACH, CALIFORNIA / ACCESS Newswire / November 6, 2025 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced the acquisition of San Diego based, IRRAS Holdings, Inc., a medical technology company focused on neurocritical care, with an emphasis on treatments for intracerebral hemorrhage, chronic subdural hematoma, and other conditions requiring intracranial fluid management. Its cornerstone product is the IRRAflow ® system, an FDA-cleared and CE-marked platform which integrates continuous irrigation, aspiration, and real-time intracranial pressure monitoring.

Accesswire • Nov 6, 2025