Trice Medical obtains FDA 510(K) clearance for mi-eye 2 disposable needle with integrated camera

9 October 2016 (Last Updated November 22nd, 2018 11:31)

Trice Medical has secured 510(k) approval from the US Food and Drug Administration (FDA) for mi-eye 2, which is a disposable needle with an integrated camera that enables physicians to use advanced diagnostic imaging to visualise joint injuries in their clinic.

Trice Medical has secured 510(k) approval from the US Food and Drug Administration (FDA) for mi-eye 2, which is a disposable needle with an integrated camera that enables physicians to use advanced diagnostic imaging to visualise joint injuries in their clinic.

Intended for use in diagnostic and operative arthroscopic and endoscopic procedures, mi-eye 2 offers illumination and visualisation of an interior cavity of the body through either a natural or surgical opening.

The mi-eye 2 also offers doctors the ability to inject or aspirate under direct visualisation.

"Our long-term goal is to eliminate the need for MRI exams and enable a quicker road to recovery."

Trice Medical senior president and CEO Jeffrey O'Donnell said: "Based on feedback we received from our surgeon advisory board, we promptly implemented and pursued FDA clearance for the next-generation mi-eye 2.

"Our team made dramatic enhancements to the technology of the mi-eye, which reflects our continued commitment to patients by introducing our technology into a medical practice, and working to ensure that the mi-eye technology becomes the standard of care for providing an immediate real-time diagnosis.

"Our long-term goal is to eliminate the need for MRI exams and enable a quicker road to recovery."

mi-eye 2 is the firm's second, next-generation FDA-cleared patented technology, which includes improvements that bolster the mi-eye's resolution, field of view, depth of field and overall visualisation.

MRI's are often inconclusive, or result in false readings, which has the potential to lengthen the timeline from diagnosis of knee- and shoulder-reated pains to recovery and not every patient is a candidate for MRI.

mi-eye 2 offers a diagnostic modality for every patient, and can provide time-savings to the patient by removing the multiple visits linked with an MRI.