Lazurite Holdings LLC in Cleveland has received regulatory clearance to market and sell its ArthroFree wireless surgical camera system in the United States.
The landmark approval from the U.S. Food & Drug Administration marks the completion of Lazurite's multi-year effort to commercialize its wireless light and camera system, which is used during minimally invasive surgery.
The idea for ArthroFree was born from the need to create a safer, more efficient operating room, said Eugene Malinskiy, Lazurite's CEO and co-founder, in his company's statement.
The ArthroFree System uses Lazurite's proprietary low-heat, high-intensity Meridiem light technology along with camera, battery and wireless transmission technologies to enable surgeons to see inside the body through tiny incisions.
"The entire endoscopic market will benefit from our minimally invasive surgical equipment advancement," Malinskiy said.
The newly cleared system was designed to improve operating room productivity, patient safety and economic value through cost-savings, energy efficiency and reduced setup/breakdown times, Lazurite said.
In August, the Cleveland-based medical technology company received an undisclosed investment from UH Ventures, the commercialization unit of University Hospitals in Cleveland, and began collaborating with the health system on research and studies of ArthroFree.
The surgical system produces excellent-quality images in a surgical field uncluttered by multiple devices and electrical cords, said Dr. Jeffrey Ustin, a trauma surgeon at University Hospitals in Lazurite's statement.
"When you pick it up and pop in the battery, it's on. In a few years, I think, this is going to be the standard," Ustin said.
In June, Lazurite raised $10 million in debt financing and changed its name. The company said it would use its financing to develop a diverse pipeline of products and expand its intellectual property portfolio.
Lazurite was the #10 seed in Cleveland Inno's inaugural Inno Madness bracket competition, which concludes this week.
