LEM Surgical receives FDA clearance for its Dynamis Robotic Surgical System
Life sciences
26 May 2025
The Dynamis Robotic Surgical System is an integrated navigation-based robotic platform designed to enhance the accuracy and control during spine surgeries. | © LEM Surgical
Bern-based medtech LEM Surgical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Dynamis Robotic Surgical System. The announcement marks a major regulatory milestone for the company and paves the way for the introduction of its next-generation spine surgery robot into U.S. hospitals.
Designed specifically for hard tissue procedures, LEM Surgical’s Dynamis Robotic Surgical System is an integrated navigation-based platform aimed at improving surgical precision and workflow efficiency in spinal interventions. The system includes three robotic arms, two for instrument guidance and one for optical navigation, consolidated into a compact, mobile design that integrates seamlessly into the operating room.
Unlike existing systems, the Dynamis platform supports a wide array of surgical tools via adjustable end effectors and an intraoperative qualification process. This approach enhances flexibility while maintaining compatibility with diverse surgical environments and hospital workflows.
“This FDA clearance represents an exciting leap forward for robotic-assisted spine surgery,” said Yossi Bar, CEO of LEM Surgical. “We’re proud to introduce the first multi-arm surgical robot dedicated to hard tissue surgery. With Dynamis, we are ushering in the next generation of intelligent robotic systems for the operating room.”
Founded in Bern, LEM Surgical is known for its commitment to combining Swiss precision engineering with surgical innovation. The company’s 19,400-square-foot headquarters, opened in 2024, houses its R&D and manufacturing teams under one roof, fostering rapid feedback between clinical, engineering, and production teams. Its U.S. operations, including the Dynamis Demonstration Suite, are located in Tampa, Florida.
“This is just the beginning,” said Chris Prentice, Chief Commercial Officer at LEM Surgical. “We will begin introducing Dynamis at select U.S. hospitals in 2025, with broader commercialization planned for 2026.”
