Trice Medical announced today that it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for mi-eye 2, a disposable needle with a fully integrated camera that enables physicians to use advanced diagnostic imaging to visualize joint injuries in their clinic. The mi-eye 2 is designed for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The mi-eye 2 also provides physicians the ability to inject or aspirate under direct visualization.
The mi-eye 2 is Trice Medical's second, next-generation FDA-cleared patented technology, which includes improvements that significantly enhance the mi-eye's resolution, field of view, depth of field and overall visualization.
"Based on feedback we received from our surgeon advisory board, we promptly implemented and pursued FDA clearance for the next-generation mi-eye 2," said Jeffrey O'Donnell, Sr., President and CEO at Trice Medical. "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."