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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
Ultrasound first for palpable lumps under 30 — add mammography only when ultrasound raises suspicion.
In women under 30, dense glandular tissue limits mammography and the pre-test probability of malignancy is low; targeted ultrasound is the first study for a palpable lump, with mammography added only for suspicious sonographic findings.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
American College of Radiology · 2024
U.S. Preventive Services Task Force · 2024
