Carestream Submits Application for FDA Clearance of OnSight 3D Extremity System

Carestream Health Inc. has filed a 510(k) application with the U.S. Food and Drug Administration for clearance of its Carestream OnSight 3D Extremity System that uses cone beam computed tomography (CBCT) technology to capture weight-bearing and other types of patient extremity images. This affordable system is designed to offer high-quality, low-dose 3D imaging for use by orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers.

“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,” said Helen Titus, Carestream’s marketing director for Worldwide CT & Ultrasound Solutions. “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.”

The company is currently conducting trials and research studies of the CBCT system in the United States and Europe. UBMD Orthopaedics & 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 computed tomography (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 Dr. John Marzo, a physician with UBMD Orthopaedics & Sports Medicine, who also is an associate professor of clinical orthopedics at the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and was former medical director for the 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 3D extremity system in pre- and post-operative cases. During the six-month project, 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 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 radiology group and official imaging provider for the Buffalo Bills and Buffalo Sabres—have also provided support to these patient studies.

ECMC includes an advanced academic medical center with 602 inpatient beds, on- and off-campus health centers, more than 30 outpatient specialty care services and a 390-bed long-term care facility. It is a major teaching facility for the University at Buffalo.

These clinical studies and other research projects will help guide Carestream’s development of new CBCT systems with the goal of designing orthopedic imaging systems that use less radiation than traditional CT; are compact and affordable; and could be used in a wide range of facilities.