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
Objective myelopathic signs mandate cervical spine MRI promptly — surgical-candidacy decisions depend on cord signal and compression severity.
Gait disturbance, hand clumsiness, hyperreflexia, or sphincter change with neck pain suggests degenerative cervical myelopathy or cord compression. MRI of the cervical spine is the definitive study and should not be deferred for a trial of conservative care.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Global Spine Journal · 2017doi:10.1177/2192568217701914
American College of Radiology · 2024