3D Extremity System Up for US FDA Clearance

By MedImaging International staff writers
Posted on 06 Apr 2016

A leading imaging vendor has filed a 510(k) application with the US FDA for clearance of its Cone-Beam Computed Tomography (CBCT).

The system is designed to capture weight-bearing and other types of 3D diagnostic images of extremities including knees, legs, feet, arms, and hands. The images are intended for orthopedic and sports medicine practices and institutions, including hospitals, urgent care facilities, and imaging centers.

$Image: Carestream\'s OnSight 3-D Extremity System provides high-quality, low-dose 3D images for use by orthopedic, and sports medicine center and other healthcare providers (Photo courtesy of Business Wire).$

Image: Carestream\'s OnSight 3-D Extremity System provides high-quality, low-dose 3D images for use by orthopedic, and sports medicine center and other healthcare providers (Photo courtesy of Business Wire).

Carestream Health (Rochester, NY, USA), a worldwide provider of dental and medical imaging systems and IT solutions, developed the OnSight 3D Extremity System and is conducting trials and research studies of the system in the US and Europe.

Carestream is conducting a clinical study together with UBMD Orthopaedics & Sports Medicine (Williamsville, NY, USA) and US Erie County Medical Center (ECMC; Buffalo, NY, USA) that is designed to help orthopedic surgeons diagnose the degree of instability of the patella more accurately, and objectively. In Europe, HUS Medical Imaging Center (Helsinki, Finland) is performing the first European clinical study of the system, and will investigate its use for imaging bone fractures, bone structure, and the level of metal artifacts.

The results of the clinical studies will be used to help Carestream design new orthopedic imaging systems that use less radiation than standard CT scanners.

Helen Titus, Marketing Director, Worldwide CT and Ultrasound Solutions, at Carestream, said, “Orthopedic 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. 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.”

Related Links:
Carestream Health
UBMD
ECMC