FDA Clearance for Lazurite’s ArthroFree Wireless Camera

By Julie A. Vetalice

FDA Clearance for Lazurite’s ArthroFree Wireless Camera

Lazurite received FDA 510(k) clearance to market the ArthroFree Wireless Camera System for the minimally invasive OR.

ArthroFree incorporates the company’s proprietary low-heat, high-intensity Meridiem™ light technology along with advanced camera, battery and wireless transmission technologies. It is designed to deliver improved operating room productivity, patient safety and economic value through cost savings, energy efficiency and reduced setup/breakdown times. The modular system also is designed to be drop-in compatible with patient data consoles, surgical displays and endoscopes found in minimally invasive operating rooms.

In 2021, Lazurite partnered with University Hospitals Ventures to conduct a formative human factors study of the ArthroFree wireless surgical camera as part of a broader multisite study.

Market launch is expected to initially focus on orthopedic applications, particularly in sports medicine.

Source: Lazurite

Product Labels: Arthroscopy Equipment

Tags: 510(k) Clearance, Regulatory