Carestream Health has filed a 510(k) application with the FDA for the clearance of its 3D cone-beam CT (CBCT) system, OnSight 3D Extremity. The system, which captures weight-bearing and other types of patient extremity images, is designed to perform low-dose 3D imaging in an orthopedic and sports medicine setting.
OnSight 3D Extremity is currently undergoing testing in both the United States and Europe, with Buffalo, NY-based UBMD Orthopaedics and Sports Medicine and Erie County Medical Center (ECMC) working alongside Carestream to conduct an institutional review board-approved clinical study. The goal, officials say, is to help orthopedic surgeons more effectively diagnose the degree of patellar instability.
“We compare images obtained on a conventional CT scanner to those obtained on the prototype CBCT scanner while the patient is standing, the quadriceps is active, and the knee is flexed to 30 degrees,” says John Marzo, MD, a physician with UBMD Orthopaedics and Sports Medicine and former medical director for the Buffalo Bills. “The orthopedic specialists involved in the clinical study are extremely satisfied with the image quality from the CBCT scanner and have provided positive feedback on the benefits provided by the use of this technology for weight-bearing exams,” he adds.
Helsinki, Finland-based HUS Medical Imaging Center is the site of the first European clinical study of Carestream’s 3D extremity system in pre- and postoperative cases. HUS radiologists will evaluate over a 6-month period the system’s level of metal artifacts, as well as its image quality in bone structures and fractures.
And in the United States, ECMC’s clinical team is conducting trials to provide feedback about OnSight 3D Extremity’s design and performance. Great Lakes Medical Imaging—which works exclusively with the Buffalo Bills and the Buffalo Sabres sports teams—is also supporting the patient studies. These clinical studies and other research projects will help guide Carestream’s development of new CBCT technologies, with the objective of creating compact orthopedic imaging systems that use less radiation than traditional CT scanners and can be used in a variety of medical settings.
For more information about the CBCT system, visit Carestream.