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 (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.

Rhea-AI Summary

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.

Positive

• EU MDR certification (CE mark) obtained for ClearPoint Navigation Software Version 3.0.2
• Adds intraoperative CT and cone-beam CT workflows to enable OR use beyond MRI-only guidance
• Builds on prior FDA clearance of Version 3.x 11 months ago and reported broad US adoption

Negative

• None.

Argus Jan 23 session

+10.34% close to close Open Argus

Details

News Market Reaction – CLPT

In the Jan 23 session, CLPT gained 10.34%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +10.3% in the session following this news. A strong positive reaction aligns with C...

Analysis

The stock surged +10.3% in the session following this news. A strong positive reaction aligns with CLPT’s history of gains following growth and regulatory milestones, such as prior revenue updates and the IRRAS acquisition. This EU MDR certification expands its navigation platform footprint in Europe, complementing FDA-cleared deployments. Investors have also faced an overhang from a resale registration covering 1,312,570 shares, so sustained strength could depend on how reselling activity and execution on the new CT-based workflows evolved.

Key Figures

Share Price: $14.21 Market Cap: $416,773,795 Daily Volume: 334,861 shares +5 more

Share Price

$14.21

CLPT pre-news level on publication date

Market Cap

$416,773,795

Equity value prior to EU MDR news

Daily Volume

334,861 shares

Compared with 20-day average volume of 627,586

52-week Range

$9.76–$30.0999

CLPT trades 52.79% below its 52-week high

Resale Registration Shares

1,312,570 shares

Registered for resale from IRRAS merger consideration

Prelim Q4 2025 Revenue

~$10.4M

Preliminary unaudited quarter revenue, 20% growth vs Q4 2024

Full-year 2025 Revenue

~$37M

Preliminary unaudited revenue for 2025

2026 Revenue Outlook

$54M–$60M

Management expectation for 2026 total revenue

Historical Context

5 past events · Latest: Jan 12

5 events

1. Jan 12

   Prelim revenue update

   24h Move

   +4.9%

   Preliminary Q4 and 2025 revenue growth with higher 2026 revenue expectations.

2. Nov 20

   Acquisition completion

   24h Move

   +2.3%

   Closed IRRAS acquisition adding IRRAflow system and >50 active customers.

3. Nov 06

   Earnings results

   24h Move

   +7.4%

   Q3 revenue growth, strong gross margin and reaffirmed 2025 guidance with IRRAS plans.

4. Nov 06

   Acquisition agreement

   24h Move

   +7.4%

   Announced agreement to acquire IRRAS with projected higher 2026 combined revenue.

5. Nov 05

   Conference participation

   24h Move

   -3.1%

   Outlined participation in several investor conferences without new fundamental data.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

eu mdr, ce mark, fda clearance, intraoperative ct, +4 more

8 terms

eu mdr regulatory

"today announced it has received EU MDR Certification for its ClearPoint Navigation"

The EU MDR is the European Union’s set of rules governing the safety, testing and approval of medical devices sold in the EU, replacing older standards with stricter requirements for clinical evidence, traceability and post‑market checks. For investors it matters because the regulation affects how quickly products can reach patients, the cost of compliance and the risk of sales delays or recalls—think of it as a building code that can slow or speed a company’s ability to open new properties.

ce mark regulatory

"By achieving CE Mark for the ClearPoint Navigation 3.0.2 software, we are able"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

fda clearance regulatory

"Software Version 3.x was first introduced in the United States following FDA clearance 11"

FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.

intraoperative ct medical

"Version 3.0.2, now available in Europe, introduces an intraoperative CT workflow"

A CT scanner used during surgery to produce real-time, cross‑sectional X‑ray images that let surgeons see anatomy and instruments while they operate. Think of it as a GPS for the operating room: it helps confirm placement, detect problems immediately, and reduce the need for repeat procedures. Investors watch adoption and reimbursement because intraoperative CT can change procedure costs, hospital capital spending and clinical outcomes, affecting device and service demand.

cone-beam ct medical

"By offering compatibility with both intraoperative CT and Cone-beam CT imaging, the software"

A cone-beam CT is a medical imaging device that takes a single, cone-shaped X-ray sweep to create a three-dimensional picture of a specific area, like a detailed 3D photo of the jaw, sinuses, or skull. Investors care because its purchase, installation, and follow-up services drive equipment sales and recurring revenue for clinics and manufacturers, and adoption or regulatory changes can shift demand across healthcare and dental markets.

stereotactic medical

"builds on over a decade of experience in stereotactic procedures. While earlier generations"

Stereotactic describes methods and tools that locate and target tiny areas inside the body with very high precision using three-dimensional coordinates, like a GPS for the brain or other organs. For investors, the term signals treatments or devices designed to reduce damage to surrounding tissue and improve outcomes, which can affect clinical success, market adoption, regulatory scrutiny, and potential reimbursement—important factors for commercial value and risk.

deep brain stimulation medical

"including deep brain stimulation (asleep or awake) lead placement."

A medical procedure that implants small electrodes into specific brain areas and uses a surgically placed pulse generator to send mild electrical signals that adjust abnormal brain activity—think of it as a pacemaker for the brain. Investors care because it represents a durable medical-device market with high development and regulatory hurdles, ongoing revenue from hardware and follow-up care, and clinical results or approvals that can materially affect company value and reimbursement prospects.

neurosurgical medical

"devices during neurosurgical procedures. These procedures include biopsies, catheter and"

Relating to surgery on the brain, spinal cord, and related nerves, neurosurgical describes procedures, tools, devices, and specialties that repair, remove, or treat disorders of the nervous system. Investors care because neurosurgical products and procedures often command high prices, require lengthy testing and approvals, and can drive durable revenue if clinically successful—think of them as precision repairs on a complex computer where a successful fix can justify large long-term returns but carries high technical and regulatory risk.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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. "We expect that this will also help us to not only satisfy our biopharma partners who want a global solution, but also reduce our operating costs and drive economies of scale."

ClearPoint Navigation Software Version 3.x was first introduced in the United States following FDA clearance 11 months ago and has already been adopted by most US customers. "By releasing our latest version of software to our EU customers, we are excited to offer feature refinements developed through years of valuable user experience and feedback," stated Tim Orr, VP of Software Development at ClearPoint Neuro. "The 3.0.2 release represents an important milestone which will allow us to unify US and EU customers on the same navigation platform."

Version 3.0.2, now available in Europe, introduces an intraoperative CT workflow that builds on over a decade of experience in stereotactic procedures. While earlier generations of ClearPoint software supported MRI-guided workflows exclusively, the 3.0.2 release extends ClearPoint navigation capabilities to the operating room. By offering compatibility with both intraoperative CT and Cone-beam CT imaging, the software is designed to increase access to precision-guided neurosurgery for facilities without intraoperative MRI capabilities. The ClearPoint Navigation Software Version 3.0.2, when used in conjunction with the SmartFrame XG stereotactic frame, is intended to provide precise stereotactic guidance when placing instruments or devices during neurosurgical procedures. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (asleep or awake) lead placement.

About ClearPoint Neuro
ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.

Forward-Looking Statements
This press release contains forward-looking statements within the context of the federal securities laws, including the Company's expectation for the future market of its products and services, expectations for reducing costs and gaining efficiencies by enablement of a unified software platform, and other performance and results. These forward-looking statements are based on management's current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: global and political instability; geopolitical trends, such as protectionism and economic nationalism; the introduction of or changes in tariffs, sanctions, or trade barriers; supply chain disruptions and macroeconomic and inflationary conditions; future revenue from sales of the Company's products and services; the Company's ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company's products and services in their delivery of therapies; the Company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company's ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company's ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products. For a detailed description of the Company's risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contact:
Media Contact:
info@clearpointneuro.com

Investor Relations:
Danilo D'Alessandro, Chief Financial Officer
(888) 287-9109
ir@clearpointneuro.com

SOURCE: ClearPoint Neuro, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did ClearPoint Neuro announce on January 22, 2026 about Version 3.0.2 (CLPT)?

ClearPoint Neuro announced EU MDR certification (CE mark) for ClearPoint Navigation Software Version 3.0.2, making it available in Europe.

How does ClearPoint Navigation 3.0.2 (CLPT) differ from earlier versions?

Version 3.0.2 extends earlier MRI-only workflows by adding intraoperative CT and cone-beam CT compatibility for operating room navigation.

Will ClearPoint Navigation 3.0.2 (CLPT) work with existing stereotactic hardware?

Yes; Version 3.0.2 is intended to be used with the SmartFrame XG stereotactic frame for precise instrument and device placement.

Does the EU MDR certification for ClearPoint 3.0.2 affect US customers (CLPT)?

The certification unifies the navigation platform globally so US and EU customers can use the same software version, per the company.

When was ClearPoint 3.x cleared by the FDA relative to the EU announcement (CLPT)?

The company notes FDA clearance of ClearPoint Navigation Software Version 3.x occurred 11 months prior to the January 22, 2026 announcement.

What clinical procedures can ClearPoint Navigation 3.0.2 (CLPT) support?

When used with SmartFrame XG, the software is intended to guide biopsies, catheter and electrode insertion, and deep brain stimulation lead placement.