LEM Surgical was granted FDA 510(k) clearance for its Dynamis Robotic Surgical System. It will be introduced in America at select hospitals this year, followed by increased commercialization in 2026.
Dynamis is an integrated navigation-based robotic platform designed to enhance accuracy and control during spine surgeries. With this clearance, U.S. spine surgeons will now have access to a next-generation technology that combines real-time imaging, dynamic guidance and adaptable instrumentation compatibility within a single platform.
The system features three robotic arms – two for surgical guidance and one for optical navigation – consolidated into a single cart that fits partially beneath the surgical table. The Dynamis Robotic Surgical System supports a wide range of surgical instruments through its adjustable end-effectors and intraoperative qualification process.
“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.”
LEM Surgical was granted FDA 510(k) clearance for its Dynamis Robotic Surgical System. It will be introduced in America at select hospitals this year, followed by increased commercialization in 2026.
Dynamis is an integrated navigation-based robotic platform designed to enhance accuracy and control during spine surgeries. With this clearance,...
LEM Surgical was granted FDA 510(k) clearance for its Dynamis Robotic Surgical System. It will be introduced in America at select hospitals this year, followed by increased commercialization in 2026.
Dynamis is an integrated navigation-based robotic platform designed to enhance accuracy and control during spine surgeries. With this clearance, U.S. spine surgeons will now have access to a next-generation technology that combines real-time imaging, dynamic guidance and adaptable instrumentation compatibility within a single platform.
The system features three robotic arms – two for surgical guidance and one for optical navigation – consolidated into a single cart that fits partially beneath the surgical table. The Dynamis Robotic Surgical System supports a wide range of surgical instruments through its adjustable end-effectors and intraoperative qualification process.
“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.”
Copy to clipboard 
