Malvern, PA (October 26, 2021) – Trice Medical has received FDA 510(k) Clearance for 25-degree mi-eye 3 needlescope™ with distinctive horizon leveling technology, clearing the way for unparalleled views and maneuverability in arthroscopic and endoscopic procedures from a single-use, single-hand device. Used with the proprietary high-resolution mi-tablet™ 3, the technology takes minimally invasive operative and diagnostic capabilities in small joints and patient outcomes to a new level.
“The 25-degree mi-eye 3 needlescope™ is a huge win for medicine. It allows physicians to expand the field of view and access areas of joints as no arthroscope has done before,” said Mark Foster, President and CEO of Trice Medical. “For decades, using an angled camera over a 0-degree camera has been the standard of care in arthroscopy. No physician would ever use a 0-degree reusable arthroscope in the operating room and now they don’t have to take a step back in quality just to use a disposable camera either. Our early data shows the potential to see over 16x more information with our angled camera vs. a 0-degree camera. This is another in a long list of worlds’ first innovations from Trice Medical.”
“I can clearly see all aspects of the joint space and visualize areas that are difficult to see with a traditional arthroscope,” said Richard Ferkel, M.D., Orthopedic Surgeon and Director of the Sports Medicine Fellowship of Southern California Orthopedic Institute. “This 25-degree camera is easy to maneuver all over the ankle and other small joints, and the image quality is comparable to reusable operating room equipment.”
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The 25-degree mi-eye 3 needlescope™ and the high-resolution mi-tablet™ 3 platform integrates the latest technology with 8-in-1 capabilities: image horizon leveling, high-resolution image sensor, integrated camera with LED illumination, single-hand operation, image management, seamless workflow with hospital information management systems, the ability to manipulate the viewing angle with horizon preferences, and portability.
“The 25-degree scope allows me to visualize a joint as I would with a traditional arthroscope at a fraction of the size. This landmark advancement enables me to perform surgery the way I’ve been trained, while enabling me to provide the patient with the expected excellent outcome in a more minimally invasive way. No other needle arthroscope on the market affords me that treatment option,” said Sean McMillan, D.O., Sports Medicine Orthopedic Surgeon.