LEM Surgical's Dynamis Robotic Surgical System Receives FDA 510(k) Clearance
LEM Surgical's Dynamis Robotic Surgical System, with three robotic arms for surgical guidance and optical navigation receives FDA 510(k) clearance for enhanced precision in spine surgeries.
According to an April 24 press release, the U.S. Food and Drug Administration granted 510(k) clearance to LEM Surgical's Dynamis Robotic Surgical System, a navigation-based platform designed to enhance precision in spine surgeries.
The system features three robotic arms—two for surgical guidance and one for optical navigation—integrated into a single cart compatible with various surgical instruments.LEM Surgical plans to introduce the system in select U.S. hospitals later this year, with broader commercialization expected in 2026.
