Trice Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its single-use 25-degree mi-eye 3 needlescope.
Claimed to be the first of kind across the world, the new single-hand device is developed to facilitate enhanced views and maneuverability in arthroscopic and endoscopic procedures.
The device is used with high-resolution mi-tablet 3 to deliver improved minimally invasive operative and diagnostic capabilities for small joints and enhanced patient outcomes.
Trice Medical president and CEO Mark Foster said: “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.
“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.”
The 25-degree mi-eye 3 needlescope and the mi-tablet 3 platform incorporates the latest technology with 8-in-1 capabilities, including image horizon leveling, high-resolution image sensor and integrated camera with LED illumination.
Other capabilities consist of single-hand operation, image management, seamless workflow with hospital information management systems, the capacity to manipulate the viewing angle with horizon preferences, and portability.
The new mi-eye 3 needlescope camera delivers the same functions similar to reusable but in a small disposable form.
According to the company, the device’s streamlined design also phases out unwanted aspects of existing reusable arthroscopes, including the two-handed light source and angle rotation requirements and multiple accident-prone cables.
In August this year, active healing solutions provider Bioventus announced a strategic investment in Trice Medical, which develops and commercialises minimally invasive technologies for sports medicine and orthopaedic surgical procedures.
