ARKA Clinical Decision Support is designed to meet all four criteria for Non-Device CDS under FD&C Act §520(o)(1)(E) and FDA's January 2026 final guidance on Clinical Decision Support Software. Recommendations support, not replace, the clinician's judgment. Every recommendation is anchored in a published guideline or peer-reviewed source, with the basis available for independent review. CLIN emphasizes imaging appropriateness at order entry.
This recommendation is intended to support, not replace, clinical judgment. It is generated by ARKA, software designed to meet the four criteria for Non-Device Clinical Decision Support under FD&C Act §520(o)(1)(E) and FDA's final guidance on Clinical Decision Support Software (January 2026). The clinician is responsible for the final decision.
AIIE Evidence
Image suspected fragility fracture — radiographs first, MRI for acuity assessment, treatment planning, or suspicion of pathologic fracture.
Acute back pain in patients with osteoporosis, chronic steroid use, or age-related fracture risk warrants imaging for vertebral compression fracture. Radiographs are an appropriate first study; MRI distinguishes acute from chronic fractures and excludes malignant collapse.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
American College of Radiology · 2024
Cochrane Database of Systematic Reviews · 2013doi:10.1002/14651858.CD008686.pub2