Carestream Health said today it filed a 510(k) application with the FDA seeking clearance for its OnSight 3D Extremity System cone-beam based extremity CT imaging device.
The Rochester, N.Y.-based company’s system is designed to provide high-quality, low-dose 3D imaging for use by orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare providers.
“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. 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,” Carestream worldwide CT & ultrasound solutions marketing director Helen Titus said in prepared remarks.
Carestream said it is currently conducting trials and research studies of the CBCT system in the U.S. and Europe, with an IRB approved clinical study ongoing at the University of Buffalo’s UBMD investigating the use of the device to diagnose the degree of instability of the patella.
“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. The orthopaedic 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,” UBMD’s Dr. John Marzo said in a prepared statement.
A 2nd study in Finland will examine the use of the device in pre and post-operative cases over 6-months. Radiologists in the study will analyze the systems’ image quality in bone structure, fractures and the level of metal artifacts, the company said.
Last October, Carestream said it won FDA 510(k) clearance for its Vue Motion universal viewer system designed for the diagnostic viewing of electrocardiogram waveforms.
The system is designed for clinicians, physicians and cardiologists to view ECG exams for patients with ST segment elevation myocardial infarction and other heart conditions and illnesses, the company said.