Loading…
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
Pre-op cardiac imaging is appropriate only for symptomatic patients or poor functional capacity before elevated-risk surgery, when results will alter management.
Cardiac imaging before non-cardiac surgery is justified when the patient has active cardiac symptoms, poor or unknown functional capacity, and elevated-risk surgery — and only when results would change management. Stress imaging or TTE is targeted to the specific question.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Journal of the American College of Cardiology · 2014doi:10.1016/j.jacc.2014.07.944
American College of Radiology · 2024
