The FDA clearance of mi-eye is a key milestone in Trice Medical’s pursuit of needle based diagnostic and therapeutic technologies. The company will also apply for CE Mark in Europe and approval in many countries outside the U.S.
King of Prussia, PA (PRWEB) September 16, 2014
King of Prussia, PA, September 16, 2014 – Trice Medical™, a private diagnostics company focused on micro invasive technologies, announced that it received 510(k) regulatory clearance from the United States Food and Drug Administration (“FDA”) for its new device, mi-eye™.
mi-eye is designed to provide a more immediate, definitive and less expensive diagnosis, eliminating the false reads of indirect modalities, such as MRIs. mi-eye is a fully disposable, single-use, streamlined visualization device that uses a standard 14-gauge needle with an integrated camera and light source to perform a diagnostic arthroscopy—all while in the physician’s office during the initial consultation. A separate LCD tablet, running on Android OS, is attached via a data cable from the mi-eye needle. mi-eye is delivered to customers in sterile packaging and ready for immediate use.
Jeff O’Donnell, Chairman and CEO of Trice Medical, commented, “The FDA clearance of mi-eye is a key milestone in Trice Medical’s pursuit of needle based diagnostic and therapeutic technologies. The company will also apply for CE Mark in Europe and approval in many countries outside the U.S.”
Trice Medical intends to execute a limited marketing launch beginning in the fourth quarter of 2014. The company is currently building inventory and developing marketing tools and educational programs in preparation for the launch.
In conjunction with the achievement of this regulatory milestone, Trice Medical received the balance of the cash related to its $11.6M Series B financing, which was led by Safeguard Scientifics, Inc. (NYSE:SFE).
About Trice MedicalTM
Trice was founded to fundamentally improve orthopedic diagnostics for the patient, physician, and payer by providing instant, eyes-on, answers. Trice has pioneered fully integrated camera-enabled needle technologies that provide a clinical solution that is optimized for the physician’s office. Trice’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system. For more information, please visit http://www.TriceMedical.com.