Axis Surgical Technologies has received 510(k) clearance from FDA to market C-MOR visualization device for use in diagnostic and operative arthroscopic and endoscopic procedures.
The self-contained portable direct-imaging tool provides illumination and visualization of an interior cavity through either a natural or surgical opening. The ergonomic lightweight device offers practitioners the convenience of endoscopic visualization and efficient one-handed operability that can be employed in hospital outpatient departments, ambulatory surgery centers, and office surgery suites.
The C-MOR visualization device is currently being used for office-based arthroscopic diagnosis. It displays real-time endoscopic images directly using an on-board LCD display, providing better utilisation of the surgeon’s natural field of view and range of motion, as well as providing immediate diagnosis for structural issues, such as ligament tears.
The intuitive design equips office-based physicians with modern imaging capabilities designed to enhance continuity of care, as well as potentially enabling the treating physician to immediately diagnose injuries without having to wait for MRI results. The application for this device will revolutionise the sports medicine field by providing office based direct visualization and diagnosis.
Fred Seddiqui, CEO of Axis Surgical, said: “This is an exciting moment for Axis Surgical Technologies as our engineering team was able to bring a novel device for minimally invasive office–based procedures to market.
“This 510(k) clearance allows for commercialization of the C-MOR and we are excited to begin execution of our sales strategy. This significant milestone is a welcomed achievement for our team and the orthopedic and sports medicine community.”
James Farnworth, director of regulatory affairs, said: “Axis Surgical has successfully completed the design process while paying close attention to domestic and international standards and regulations.”