Trice Medical Granted FDA 510(k) for mi-eye 3 needlescope

By Julie A. Vetalice

Trice Medical Granted FDA 510(k) for mi-eye 3 needlescope

Trice Medical received FDA 510(k) Clearance for 25-degree mi-eye 3 needlescope™ with horizon leveling technology, offering 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 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 new mi-eye 3 needlescope camera performs the same as a reusable but in a small disposable form. Its streamlined design eliminates undesirable aspects of existing reusable arthroscopes, including the two-handed light source and angle rotation requirements and multiple accident-prone cables. It also removes costly equipment, sterile processing, and other expenses.

Mark Foster, President and CEO of Trice Medical, said, “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.”

Source: Trice Medical

Product Labels: Arthroscopy Equipment

Tags: 510(k) Clearance, Regulatory