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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
Characterize every thyroid nodule with ultrasound and apply TI-RADS — FNA decisions follow sonographic risk, not nodule presence alone.
Dedicated thyroid ultrasound is the universal first study for a palpable or incidentally detected thyroid nodule. ACR TI-RADS and ATA sonographic patterns stratify malignancy risk and set size thresholds for FNA, avoiding biopsy of low-risk nodules.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Journal of the American College of Radiology · 2017doi:10.1016/j.jacr.2017.01.046
Thyroid · 2016doi:10.1089/thy.2015.0020
American College of Radiology · 2024
