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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
CCTA is an excellent first test for intermediate-risk stable chest pain — high negative predictive value and outcome-improving plaque visualization.
For intermediate-risk stable chest pain, coronary CT angiography is a guideline-endorsed first-line test (2021 AHA/ACC, class 1A for this population). SCOT-HEART demonstrated reduced downstream MI when CCTA guided management.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Circulation · 2021doi:10.1161/CIR.0000000000001029
New England Journal of Medicine · 2018doi:10.1056/NEJMoa1805971
New England Journal of Medicine · 2015doi:10.1056/NEJMoa1415516
