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 neck masses get contrast-enhanced CT of the neck and urgent otolaryngology referral — do not delay for a trial of antibiotics.
Neck masses with fixation, rapid growth, associated otalgia, dysphagia, weight loss, or smoking history carry a high probability of head and neck cancer. Contrast-enhanced CT plus prompt specialist referral is the expedited pathway.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Otolaryngology–Head and Neck Surgery · 2017doi:10.1177/0194599817722550
American College of Radiology · 2024