March 24, 2016 — Carestream Health has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance of its OnSight 3-D Extremity System. The system uses cone beam computed tomography (CBCT) technology to capture weight-bearing and other types of patient extremity images. It is designed to offer high-quality, low-dose 3-D imaging for use by orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers.
The company is currently conducting trials and research studies of the CBCT system in the United States and Europe. UBMD Orthopedics & Sports Medicine (Buffalo, N.Y.), Erie County Medical Center (Buffalo, N.Y.) and Carestream are conducting an institutional IRB-approved clinical study designed to help orthopedic surgeons more accurately and objectively diagnose the degree of instability of the patella (knee cap).
“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,” said John Marzo, M.D., a physician with UBMD Orthopedics & Sports Medicine, associate professor of clinical orthopedics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo and former medical director, Buffalo Bills.
“The orthopedic specialists involved in the clinical study are extremely satisfied with 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 added.
HUS Medical Imaging Center (Helsinki, Finland) is the site of the first European clinical study of Carestream’s 3-D extremity system in pre- and post-operative cases. During the six-month project, experienced radiologists will evaluate the system’s image quality in bone structure, fractures and the level of metal artifacts.
Radiologists, technologists and other team members at Erie County Medical Center (ECMC) have provided valuable feedback on the system’s design and performance during research studies and trials conducted at their facility. Medical staff from Great Lakes Medical Imaging — a leading radiology group and official imaging service of the Buffalo Bills and the Buffalo Sabres — also have provided support to these patient studies.
For more information: www.carestream.com