Restore Robotics announced it has received additional 510(k) clearances from the FDA for the remanufacturing of two more da Vinci Xi robotic surgical instruments.
“These additional FDA clearances mark another major step forward in our effort to transform the economics of robotic surgery,” said Clif Parker, CEO of Restore Robotics, in a statement. “By expanding our remanufacturing capabilities across more high-utilization instruments, we are enabling healthcare providers to significantly reduce costs while maintaining the performance and reliability surgeons expect.”
Through its partnership with Encore Medical Device Repair, Restore Robotics said it will continue to scale distribution of its remanufactured instruments nationwide.
Hospitals participating in the Restore Robotics remanufacturing program benefit from:
- Cost reductions versus OEM instruments
- Increased sustainability through instrument reuse
- Integration into existing robotic surgery workflows
“Bringing additional robotic instruments through the FDA clearance process is a monumental task, and this milestone is a direct result of the dedication and expertise of our engineering and regulatory teams,” said Kevin May, COO of Restore Robotics. “Their work is forging the way for hospitals to access more sustainable robotic instrument solutions while realizing significant cost savings across their robotic surgery systems.”
