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October 27, 2021

US FDA grants 510(k) clearance for Trice Medical’s mi-eye 3 needlescope

The device helps to provide visuals of interior body cavities through a natural or surgical opening.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Trice Medical’s single-use 25° mi-eye 3 needlescope.

The single-hand device, with horizon levelling technology, is an orthopaedic imaging solution that helps physicians perform full diagnostic arthroscopy on a high-resolution mi-tablet 3.

It facilitates unparalleled views and manoeuvrability in arthroscopic as well as endoscopic procedures.

Additionally, the 25° needle arthroscope gives surgeons the required tools to view more pathology. The mi-eye 3 needlescope helps in providing illumination and visuals of the body’s interior cavity through a natural or surgical opening.

Trice Medical president and CEO Mark Foster said: “The 25° 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° camera has been the standard of care in arthroscopy.

“No physician would ever use a 0° 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.”

Both the device and mi-tablet 3 platform have the latest technology with eight-in-one capabilities that include a high-resolution image sensor, single-hand operation and image horizon levelling.

They also include image management, an integrated camera with LED illumination, seamless workflow with hospital information management systems, portability, and the ability to change the viewing angle with horizon preferences.

The company stated that the design of the new mi-eye 3 needlescope camera is streamlined and eliminates unwanted aspects of existing reusable arthroscopes while also removing the need for costly equipment and sterile processing.

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