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Home » LEM Surgical wins FDA clearance for hard tissue surgical robot

LEM Surgical wins FDA clearance for hard tissue surgical robot

April 25, 2025 By Sean Whooley

LEM Surgical Dynamis surgical robot system
The Dynamis surgical robotic system. [Image courtesy of LEM Surgical]
LEM Surgical announced that it received FDA 510(k) clearance for its Dynamis robotic surgical system for hard tissue surgery.

Bern, Switzerland-based LEM Surgical has its U.S. offices and a surgical demonstration suite for its robot in Tampa, Florida. It designed Dynamis as an integrated, navigation-based robotic platform. It enhances accuracy and control during spine surgeries. Clearance provides U.S. spine surgeons with the next-generation technology that combines real-time imaging, dynamic guidance and adaptable instrumentation compatibility within a single, versatile platform.

Dynamis features three robotic arms, with two for surgical guidance and one for optical navigation. They consolidate into a single cart that fits partially beneath the surgical table. Unlike currently available systems, LEM Surgical says its system supports a wide range of surgical instruments through unique, adjustable end-effectors and intraoperative qualification. This enhances compatibility and hospital workflow efficiency.

[For more on the wide world of surgical robotics, download our free special report on the space.]

LEM Surgical aims to “advance the field of robotic surgery,” CCO Chris Prentice said in a news release. The company expects to introduce Dynamis at select American hospitals this year before a larger rollout in 2026.

“This FDA clearance of the Dynamis Robotic Surgical System is a testament to the hard work of our team and our commitment to launching robotic surgery platforms that benefit the healthcare system and improve clinical outcomes,” said Yossi Bar, CEO of LEM Surgical. “We are very proud to introduce to the world the first-of-its-kind, multi-arm surgical robot for hard tissue surgery. The next generation of intelligent and highly capable robots for the operating room has begun, and LEM Surgical is positioned to lead the way.”

Filed Under: 510(k), Food & Drug Administration (FDA), 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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