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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
New-onset headache over age 50 merits neuroimaging (MRI preferred non-acutely) plus ESR/CRP when giant cell arteritis is plausible.
A genuinely new or changed headache beginning after age 50 carries a higher probability of secondary cause, including neoplasm and giant cell arteritis. Guidelines lower the imaging threshold in this group relative to younger adults with primary headache syndromes.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Annals of Emergency Medicine · 2019doi:10.1016/j.annemergmed.2019.07.009
American College of Radiology · 2024
