LEM Surgical receives FDA clearance for Dynamis robotic surgical system
The U.S. FDA granted 510(k) clearance to LEM Surgical's Dynamis navigation-based robotic platform for spine surgery.
Evidence notes
- Dynamis combines real-time imaging, dynamic guidance and adaptable instrumentation compatibility.
- The clearance opened access to the system for U.S. spine surgeons.
- LEM designed the platform to improve accuracy and control in navigation-based spine procedures.
Company context
LEM Surgical develops robotic systems for hard-tissue surgery. Its Bern-based Dynamis platform is designed around high-precision bone procedures, combining surgical robotics, navigation and Swiss medical-device engineering for orthopaedic and related operating-room workflows.