Clearances expand options for hospitals seeking lower-cost alternatives to OEM robotic surgical instruments.
Restore Robotics has received US Food and Drug Administration (FDA) 510(k) clearance for the remanufacturing of two additional da Vinci Xi robotic surgical instruments, the permanent cautery hook and permanent cautery spatula.
The newly cleared instruments expand the company’s portfolio of remanufactured devices for robotic-assisted surgery, an area where hospitals continue to face high equipment and accessory costs.
“These additional FDA clearances mark another major step forward in our effort to transform the economics of robotic surgery,” says Clif Parker, CEO of Restore Robotics, in a release. “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.”
Restore Robotics works in partnership with Encore Medical Device Repair to distribute its remanufactured instruments in the US.
“Expanding the number of remanufactured robotic instruments available to hospitals is a natural progression in advancing responsible healthcare,” says Tom Milano, president and COO of Encore Medical Device Repair, in a release. “This continued collaboration represents a significant opportunity to improve both cost efficiency and environmental stewardship in surgical care.”
Restore Robotics notes that the expanded offering is intended to provide hospitals and ambulatory surgery centers with additional options for managing robotic instrument costs while maintaining compatibility with existing surgical systems.
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