Rochester, NY-headquartered Carestream Health has recently filed a 510(k) application with the US Food and Drug Administration for its CARESTREAM OnSight 3D Extremity System, which is designed to capture low-dose 3D images.
“Orthopaedic imaging is a major focus for Carestream because of the prevalence of musculoskeletal conditions among people of all ages. Youth and adults often suffer sports-related injuries to their knees, ankles and feet while older adults experience arthritis, joint instability, meniscus loss, and other conditions,” explains Helen Titus, Carestream’s marketing director for Worldwide CT & Ultrasound Solutions, in a media release from Carestream Health.
“Our goal is to offer a compact, affordable imaging system that enables a variety of healthcare providers to produce extremely high-quality 3D images of extremities, including weight-bearing exams,” she adds.
Trials of the system are currently being conducted in the United States and Europe. In the US, UBMD Orthopaedics & Sports Medicine (Buffalo, NY), Erie County Medical Center (Buffalo, NY), and Carestream are conducting an institutional IRB-approved clinical study designed to help orthopaedic surgeons more accurately and objectively diagnose the degree of instability of the patella (knee cap).
In a 6-month clinical study taking place at HUS Medical Imaging Center in Helsinki, Finland, radiologists will evaluate the system’s image quality in bone structure, fractures and the level of metal artifacts, according to the release.
For more information, visit Carestream Health.
[Source(s): Carestream Health, Business Wire]
