Cleveland-based medical device and technology company Lazurite Holdings LLC (formerly Indago) announces its collaboration with The Center for Health Affairs, the leading advocate for Northeast Ohio hospitals, and its business affiliate CHAMPS Healthcare, to bring new smart surgical tools to market and to operating rooms across Northeast Ohio and the United States.
Co-founded in 2015 by CEO Eugene Malinskiy, Lazurite is developing novel technologies for the future of surgical care with a smart platform for a highly efficient, tech-enabled suite of tools. The company’s product pipeline features the modular ArthroFree wireless camera system, which is expected to be the first FDA-approved fully wireless minimally invasive camera system platform designed for the operating room; ORFree, a prototype portable and wireless surgical tower in a briefcase designed for use with the ArthroFree wireless camera; and others based on the company’s novel and patented Meridiem light engine technology.
“This collaboration is yet another example of the game-changing health innovation that is underway in Northeast Ohio,” says Brian Lane, president and chief executive officer for The Center for Health Affairs and CHAMPS Healthcare. “For more than 100 years we have proven our commitment to impacting healthcare through the development of products and services in northeast Ohio and launching them nationally. True to our mission, The Center for Health Affairs’ guiding principles are to influence innovation and ultimately be a catalyst for healthcare transformation. The team at Lazurite is ready to revolutionize the operating room and we are excited to be part of that journey.”
“We are thrilled to collaborate with The Center for Health Affairs and CHAMPS Healthcare as we plan for the approval and launch of our first product, ArthroFree, which was developed in response to inefficiencies that we and our surgeon stakeholders identified in the OR,” Malinskiy says. “The endorsement from such respected organizations means a lot in the healthcare market.”
The ArthroFree fully wireless minimally invasive camera system is designed to seamlessly integrate into existing operating room workflows, empowering surgeons to focus on their patients and procedures, not their tools. The device is designed to be drop-in compatible with existing systems to reduce friction of implementation. It is expected to drive value for both hospitals and outpatient surgical facilities with efficiency gains, reduced sterilization requirements through eliminating cords and cables, and significant reduction of risks of OR burns and fires with its proprietary Meridiem light engine.
The ArthroFree wireless arthroscopic camera system has not yet received FDA clearance and is not currently approved for human use. It is not intended for commercial distribution; orders cannot be accepted at this time. The company plans to submit its 510(k) premarket notification in late 2021 and expects to receive FDA approval to launch the product in the first half of 2022.