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
Gross hematuria in adults requires CT urography plus cystoscopy — anticoagulation never explains away visible blood.
Visible hematuria carries a substantial malignancy risk in adults and warrants complete evaluation: CT urography for the upper tracts plus cystoscopy for the bladder, regardless of anticoagulation status.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Journal of Urology · 2020doi:10.1097/JU.0000000000001297
American College of Radiology · 2024