LEM Surgical has received a new FDA 510(k) clearance for its Dynamis robotic surgical system, expanding the platform’s capabilities in spine surgery and marking its second FDA clearance in 2026.
The approval adds individual vertebra tracking, a robotic bi-manual stabilization workflow, and support for cervical spine procedures. The new capabilities enable surgeons to continuously track multiple vertebrae during surgery and perform more precise spinal alignment and stabilization.
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Dynamis features a unique humanoid architecture with three robotic arms—two for surgical guidance and one for optical navigation—integrated into a compact platform designed to fit within existing operating room workflows. The system also supports third-party surgical instruments and implants.
CEO Yossi Bar said:
“Our second FDA clearance marks a pivotal step forward. For the first time, a surgical robot can independently and continuously track multiple vertebrae using one arm to stabilize and control a specific segment while the second arm executes clinical intervention.”
The clearance strengthens LEM Surgical’s position in the growing robotic spine surgery market and expands the clinical applications of its next-generation surgical platform.
