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Home » LEM Surgical wins new FDA clearance for humanoid surgical robot

LEM Surgical wins new FDA clearance for humanoid surgical robot

June 23, 2026 By Sean Whooley

LEM Surgical new FDA clearance Dynamis Robotic Surgical System
The Dynamis robotic surgical system [Image courtesy of LEM Surgical]
LEM Surgical announced today that the FDA granted a new 510(k) clearance for its Dynamis robotic surgical system.

Bern, Switzerland-based LEM Surgical said the milestone introduces further capabilities to its surgical humanoid architecture for the global orthopedic and spine surgery market. It adds individual vertebra tracking using miniature bone‑mounted markers, robotic bi-manual stabilization workflow option, and the introduction of cervical indications.

LEM Surgical designed Dynamis as an integrated, navigation-based robotic platform. The system’s unique upper torso humanoid configuration consolidates into a single compact cart that fits partially beneath the surgical table. It also supports a range of third-party surgical instruments and implants. This optimizes hospital workflow efficiency and  reduces facility adoption friction.

Dynamis features three robotic arms, with two for surgical guidance and one for optical navigation. It aims to enhance intraoperative accuracy, control and clinical predictability.

LEM Surgical Dynamis surgical robot system
The Dynamis surgical robotic system. [Image courtesy of LEM Surgical]
The latest FDA clearance provides U.S. spine surgeons with simultaneous bilateral workflow, continuous independent tracking of multiple vertebrae, and intraoperative quantification of spinal realignment. It builds upon the initial FDA clearance for Dynamis, earned in April 2025.

Yossi Bar, CEO of LEM Surgical, said:

“For over two decades, the standard architecture in hard tissue robotics has relied on a single robotic arm tethered to a stationary navigation camera. 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. This upper torso humanoid design enables a safer, highly controlled, and predictable environment that is essential for scalability. We are committed to reshaping the hard tissue landscape by delivering a superior platform capable of executing advanced clinical interventions in previously untapped areas.”

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Health Technology, Orthopedics, Regulatory/Compliance, Robotic-Assisted, Spine, Surgical, Surgical Robotics Tagged With: FDA, LEM Surgical

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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