Globus Scores 510(k) Approval for GPS Guidance System

Globus Medical secured 510(k) approval from the FDA for its GPS robotic guidance and navigation system.

The device, the Excelsius, works with three different imaging technologies to integrate implants and instruments. It is compatible with pre-operative, intra-operative and post-operative CT and fluoroscopic imaging.

The company plans a worldwide launch and is increasing investment in R&D, technology acquisition and distribution channels following the approval.