Bern-based LEM Surgical secures second FDA clearance for its Dynamis surgical robot

LEM Surgical, a Bern-based developer of robotic technologies for hard tissue surgery, has received a second FDA 510(k) clearance for its Dynamis Robotic Surgical System, adding new capabilities for spine surgery.

LEM Surgical, a Bern-based developer of advanced robotic technologies for hard tissue surgery, has received a second 510(k) clearance from the United States Food and Drug Administration (FDA) for its Dynamis Robotic Surgical System. The clearance adds new capabilities to the platform, which targets the global orthopedic and spine surgery market.

The Dynamis system is an integrated, navigation-based robotic platform designed to improve accuracy, control and predictability during surgery. With this latest clearance, U.S. spine surgeons gain access to features including a simultaneous bilateral workflow, continuous independent tracking of multiple vertebrae, and intraoperative quantification of spinal realignment.

The platform uses an upper-torso humanoid configuration with multiple robotic arms, allowing one arm to stabilize and control a specific vertebral segment while another carries out the clinical intervention. According to the company, this architecture moves beyond the long-standing standard of a single robotic arm tethered to a stationary navigation camera, enabling a more controlled and scalable surgical environment. The first FDA clearance for the Dynamis system was granted in April 2025.

LEM Surgical maintains its U.S. offices and a demonstration suite in Tampa, Florida, while keeping its base in Bern.