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
Lead with ECG and hs-troponin for suspected ACS; chest X-ray for alternatives, and CCTA selectively in low–intermediate risk non-diagnostic cases.
Suspected ACS is triaged with serial ECGs and high-sensitivity troponin, not anatomic imaging. Chest radiography evaluates alternatives; coronary CTA has a role in low-to-intermediate risk patients with non-diagnostic initial workup per the 2021 AHA/ACC chest pain guideline.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Circulation · 2021doi:10.1161/CIR.0000000000001029
American College of Radiology · 2024