FDA grants Axis Surgical Technologies marketing clearance for C-MOR Visualization Device

Axis Surgical Technologies, Inc., announced today that it has received 510(k) clearance from the Food and Drug Administration to market their 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. The C-MOR™ displays real-time endoscopic images directly using an on-board LCD display, providing better utilization 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 revolutionize the sports medicine field by providing office based direct visualization and diagnosis. Axis Surgical CEO Fred Seddiqui remarks, "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." Furthermore, "Axis Surgical has successfully completed the design process while paying close attention to domestic and international standards and regulations," comments Regulatory Affairs Director, James Farnworth.

"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", says Seddiqui.

SOURCE Axis Surgical Technologies, Inc.