Globus Medical Gains 1% After EU CE Approval

Announcement

Globus Medical, Inc. (NYSE:GMED) reported that its Excelsius3D intra‑operative imaging system received CE mark approval for commercial sale in the European Union and United Kingdom. Following the announcement, the company’s shares increased approximately 1% in after‑hours trading on Thursday, 4 September 2026.

Product Details

The Excelsius3D is a mobile imaging platform that combines 3‑D cone‑beam computed tomography, 2‑D fluoroscopy and digital radiography in a single system. It can operate as a stand‑alone intra‑operative imaging device or be integrated with Globus Medical’s ExcelsiusGPS robotic navigation system, enabling combined imaging and robotic navigation during surgical procedures. The system is indicated for adult and pediatric patients where physicians require 2‑D and 3‑D visualization of anatomic structures and high‑contrast objects such as bone and metallic implants.

Regulatory Background

The Excelsius3D previously obtained U.S. Food and Drug Administration 510(k) clearance in 2021. The new CE marking now permits commercialisation of the device in EU and UK markets.

Executive Comment

Keith Pfeil, President and Chief Executive Officer of Globus Medical, stated that the CE mark for Excelsius3D represents an important milestone in the continued expansion of the Excelsius ecosystem.