BERN, SWITZERLAND, June 23, 2026 (Newswire.com) – LEM Surgical Inc., a pioneer in advanced robotic technologies for hard tissue surgery, today announced that the U.S. Food and Drug Administration (FDA) has granted an additional 510(k) clearance for its Dynamis Robotic Surgical System. This landmark milestone introduces further capabilities to the groundbreaking, surgical humanoid architecture that is focused on the global orthopedic and spine surgery market.
The Dynamis Robotic Surgical System is an integrated, navigation-based robotic platform engineered to enhance intraoperative accuracy, control, and clinical predictability. With this latest regulatory milestone, U.S. spine surgeons will gain access to a next-generation technology that allows for simultaneous bilateral workflow, continuous independent tracking of multiple vertebrae, and intraoperative quantification of spinal realignment.
“For over two decades, the standard architecture in hard tissue robotics has relied on a single robotic arm tethered to a stationary navigation camera,” said Yossi Bar, CEO of LEM Surgical. “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.”
The Dynamis system features a unique upper torso humanoid configuration consolidated into a single compact cart that fits partially beneath the surgical table. Unlike traditional closed systems, the system supports a wide range of 3rd party surgical instruments and implants through its robotic adjustable end-effectors and a proprietary intraoperative qualification process, significantly optimizing hospital workflow efficiency and reducing facility adoption friction.
About LEM Surgical Inc.
LEM Surgical Inc. is dedicated to advancing next-generation robotic solutions that elevate the standard of care for complex hard tissue procedures. Headquartered in Bern, Switzerland, with U.S. corporate operations and demonstration suite located in Tampa, Florida, the company develops intelligent humanoid robotic architectures.
For more information, please visit www.lemsurgical.com or contact communications@lemsurgical.com.
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LEM Surgical Inc.
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SOURCE: LEM Surgical AG