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
Annual low-dose chest CT is recommended for adults 50–80 with ≥20 pack-years smoking history (current or quit <15 years).
Adults aged 50–80 with at least 20 pack-years who currently smoke or quit within 15 years benefit from annual low-dose CT screening, which reduced lung-cancer mortality by 20% versus radiography in the NLST. Shared decision-making and smoking cessation counseling are integral.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
U.S. Preventive Services Task Force · 2021
New England Journal of Medicine · 2011doi:10.1056/NEJMoa1102873