Dynamic Digital Radiography Receives FDA Clearance on Chiropractic Straight Arm

By News Release

20/20 Imaging, a division of Konica Minolta, has received US FDA 510(k) clearance for the Chiropractic Straight Arm (CSA) system with Dynamic Digital Radiography (DDR). DDR is an X-ray technology that enables the visualization of anatomy in motion so clinicians can interpret the dynamic interaction of anatomical structures, such as tissue and bone, with physiological changes over time. The combination of the advanced imaging of the CSA with DDR will further enhance the diagnosis and management of musculoskeletal conditions.

DDR is not fluoroscopy; it is a series of individual digital images acquired at high speed and low dose. In the same study, clinicians can acquire static and dynamic images. The resulting cine loop delivers up to 20 seconds of anatomy in motion in a diagnostic-quality view with a simple acquisition performed on a conventional DR system. DDR has been adopted by academic and community hospitals, orthopedic and spine clinics, and pulmonary centers across the US.

The compact, efficient CSA features an array of advanced design innovations to optimize workflow, increase efficiency and improve outcomes, expediting the diagnostic process and elevating the patient experience. A 17” x 17” field-of-view detector captures high-resolution images in seconds, delivering detailed bone and soft tissue visualization. Predetermined anatomy-specific positioning and source-to-image receptor distance simplifies use for a more efficient workflow. A full range of motion enables all imaging views required while accommodating patients who are standing, sitting, lying on a table or in a wheelchair. The ability to capture and visualize the cervical spine in motion during flexion and extension with DDR will provide additional information to chiropractors and injury lawyers when documenting whiplash injuries.

“Chiropractors have shown significant interest in DDR as a tool for the visualization of movement and diagnosis of abnormalities,” says Bob Salzman, President of 20/20 Imaging. “CSA with DDR is the next generation imaging solution allowing chiropractors to examine and measure a patient’s biomechanics and musculoskeletal injury, including whiplash, and more confidently evaluate treatment follow-up. Designed to boost clinical capabilities to the next level by capturing patient movement, CSA with DDR gives chiropractors the immediate results they need to make informed decisions faster.”

Guillermo Sander, PhD, Marketing Director for Digital Radiography at Konica Minolta Healthcare adds, “DDR is transforming the role of radiography across clinical conditions, from musculoskeletal injuries to pulmonary diseases and swallowing studies. As the only technology of its kind available today, DDR adds significant clinical value with an exam that is fast and versatile at a low radiation dose. At Konica Minolta, we envision a world where advanced X-ray capabilities provide the immediacy of information that clinicians need, at a lower cost than other imaging systems, so they can make better decisions, sooner.”

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A suite of applications is available today for advanced analysis of pulmonary dynamics using DDR images. John Sabol, PhD, Clinical Research Manager for Konica Minolta Healthcare, notes that development of this technology is just beginning. "Research and development are underway to develop artificial intelligence tools that will enable accurate analysis of orthopedic and musculoskeletal images. These applications will enable quantification of skeletal motion and efficient reporting."

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