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
EXPEDITE: unstable patient + positive FAST → operating room. CT is reserved for patients who stabilize with resuscitation.
Hemodynamically unstable blunt trauma patients should not travel to CT. Bedside FAST identifies free fluid in seconds; a positive FAST in an unstable patient is an indication for immediate operative exploration.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Cochrane Database of Systematic Reviews · 2015doi:10.1002/14651858.CD004446.pub4
American College of Radiology · 2024