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
Red-flag thoracic back pain goes straight to MRI (with contrast for suspected infection or malignancy) — the thoracic cord tolerates little delay.
Thoracic pain with cancer history, fever, immunosuppression, or progressive neurologic signs raises metastasis, infection, or cord compression — diagnoses where the thoracic cord's vulnerability makes delay costly. Contrast-enhanced MRI is the study of choice.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Cochrane Database of Systematic Reviews · 2013doi:10.1002/14651858.CD008686.pub2
American College of Radiology · 2024