Clearance expands the Henderson, Nevada–based company’s portfolio of cleared instruments for remanufacturing. It aims to provide hospitals and surgery centers with cost-effective, high-quality, sustainable alternatives to purchasing new robotic instruments from original equipment manufacturers.
Restore Robotics remanufactures robotic surgical instruments to enhance affordability and sustainability. Last year, the company announced the first-in-human use of a remanufactured Intuitive da Vinci Xi robotic instrument on a patient using the newest model robotic surgical system, the da Vinci 5. The company holds the only clearance from the FDA to remanufacture Xi robotic instruments.
(Learn more about the surgical robotics space in our MassDevice Surgical Robotics Special Report. Download the report for free here.)
Last year, some analysts and investors reacted negatively to the rollout of Restore Robotics’ offerings, citing increased competition only further complicated by remanufactured instruments. However, BofA analysts quashed concerns, with reprocessing expected to only affect a small share of the robotics market.
Restore Robotics plans to use its partnership with Encore Medical Device Repair to continue scaling distribution of its remanufactured instruments nationwide. It expects the expanded offering to deliver greater savings for hospitals across a broader portion of robotic instrument spend.
Commentary from Restore Robotics and Encore officials
Clif Parker, CEO of Restore Robotics, said:
“These additional FDA clearances mark another major step forward in our effort to transform the economics of robotic surgery. 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.”
Tom Milano, Encore president and COO, said:
“Expanding the number of remanufactured robotic instruments available to hospitals is a natural progression in advancing responsible healthcare. This continued collaboration represents a significant opportunity to improve both cost efficiency and environmental stewardship in surgical care.”
