Globus Medical Announces CE Mark for Excelsius3D™ Imaging System
Globus Medical secured CE marking for its Excelsius3D imaging system, enabling EU and UK commercialization and integration with ExcelsiusGPS robotic navigation.
Rhea-AI Summary
Globus Medical (GMED) announced that its Excelsius3D™ intelligent 3‑in‑1 imaging system has received CE marking for commercial sale in the European Union and the United Kingdom. The system expands the Excelsius™ Ecosystem and is designed to enhance the ExcelsiusGPS™ robotic navigation platform.
Excelsius3D™ combines 3D cone‑beam CT, 2D fluoroscopy, and digital radiography in a single mobile, intraoperative imaging platform. It can function as a stand‑alone system or be fully integrated with ExcelsiusGPS™, supporting a streamlined surgical workflow. The system previously received U.S. FDA 510(k) clearance in 2021, and Globus Medical will now begin commercialization in EU and UK markets.
Positive
- CE mark enables EU and UK commercialization for Excelsius3D™ intelligent 3‑in‑1 imaging system
- Integration with ExcelsiusGPS™ supports combined intraoperative imaging and robotic navigation workflows
- Multi‑modal imaging with 3D cone‑beam CT, 2D fluoroscopy, and digital radiography in one mobile platform
- Regulatory traction supported by prior U.S. FDA 510(k) clearance received in 2021
Negative
- None.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 26 | Acquisition announcement | Positive | -0.7% | Acquisition of Higgs Boson Health for AI-driven digital healthcare solutions |
| Aug 06 | 2Q26 earnings report | Positive | +1.6% | Higher non-GAAP EPS and raised full-year EPS guidance |
| Jul 16 | Earnings scheduling notice | Neutral | -4.8% | Second-quarter results scheduled for August 6, 2026 |
| May 07 | 1Q26 earnings report | Positive | -8.4% | Higher quarterly sales, earnings, and raised non-GAAP EPS guidance |
| Apr 16 | Earnings scheduling notice | Neutral | +2.7% | First-quarter results scheduled for May 7, 2026 |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
GMED's recent earnings announcements produced mixed reactions, including two negative divergences despite positive reported results.
Key Terms
ce mark regulatory
510(k) clearance regulatory
cone-beam computed tomography technical
fluoroscopy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Excelsius3D™ – Intelligent 3-in-1 Imaging System Expands Excelsius™ Ecosystem in the European Union
AUDUBON, Pa., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal technology company, today announced that the Excelsius3D™ intelligent 3-in-1 imaging system is now CE marked for commercial sale in the European Union and the United Kingdom. The addition of Excelsius3D™ expands the company’s Excelsius™ Ecosystem of enabling technologies and further enhances the capabilities of the ExcelsiusGPS™ robotic navigation system in the European Union.
Excelsius3D™ is an intelligent, mobile imaging platform that combines 3D cone-beam computed tomography (CT), 2D fluoroscopy, and digital radiography in a single system. Designed for intraoperative use, Excelsius3D™ seamlessly integrates with ExcelsiusGPS™, enabling intraoperative imaging and robotic navigation to work together within a streamlined procedural workflow. Its compact footprint and omnidirectional wheels facilitate easy positioning and transport within the operating room, while providing surgeons and operating room teams with multiple imaging modalities in one comprehensive platform.
“The CE mark for Excelsius3D™ represents an important milestone in the continued expansion of the Excelsius™ Ecosystem,” said Keith Pfeil, President and Chief Executive Officer of Globus Medical. “We are committed to bringing innovative enabling technologies to surgeons around the world, and this important milestone further expands the capabilities of our platform by combining intraoperative imaging with the robotic navigation capabilities of ExcelsiusGPS™ across the European Union.”
“Excelsius3D™ was developed with a focus on bringing advanced imaging capabilities into a mobile platform that can integrate within the surgical workflow,” said Norbert Johnson, Chief Technology Officer of Globus Medical. “Its integration with ExcelsiusGPS™ represents an important step in connecting imaging, navigation, and robotics within the Excelsius™ Ecosystem, providing surgeons with complementary technologies designed to work together throughout the surgical workflow.”
Excelsius3D™ is designed to function as a stand-alone intraoperative imaging platform or as an integrated component of the Excelsius™ Ecosystem with ExcelsiusGPS™. This flexibility allows hospitals and surgical teams to leverage the system’s advanced imaging capabilities across a range of intraoperative applications while also supporting an integrated imaging and robotic navigation workflow when used with ExcelsiusGPS™.
The Excelsius3D™ system received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2021. With CE marking, Globus Medical will begin commercializing Excelsius3D™ in the European Union and United Kingdom markets.
For more information about Globus Medical and the Excelsius™ Ecosystem, visit https://www.globusmedical.com/musculoskeletal-solutions/excelsiustechnology/.
Indications for Use
Excelsius3D™ is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high X-ray attenuation such as bony anatomy and metallic objects. Excelsius3D™ images are compatible with image guided systems such as ExcelsiusGPS™.
About Globus Medical, Inc.
Globus Medical, Inc. is a leading global musculoskeletal technology company dedicated to solving unmet clinical needs and changing lives. We innovate with inspired urgency, provide world-class education and clinical support, and advance care throughout spine, orthopedic trauma, joint reconstruction, biomaterials, and enabling technologies. Additional information can be accessed at www.globusmedical.com.
Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations, and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties, and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, the risks and costs associated with health epidemics, pandemics, and similar outbreaks, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, the successful integration of businesses that we have acquired or may acquire in the future, and other risks. For a discussion of these and other risks, uncertainties, and other factors that could affect our results, refer to the disclosures contained in our most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”), including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our subsequent filings with the SEC. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. Except as may be required by applicable law, we undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof. As used herein, the “Company,” “Globus”, “Globus Medical,” “we,” “us,” and “our” refers to Globus Medical, Inc.
Contact:
Brian Kearns
Senior Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com | www.globusmedical.com
