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
EXPEDITE: immediate non-contrast head CT (plus CTA for LVO triage) — eligibility for alteplase within 4.5 hours depends on it.
Suspected stroke inside the thrombolysis window is a time-critical imaging emergency. Non-contrast CT excludes hemorrhage before thrombolysis, and CTA identifies large-vessel occlusion for thrombectomy triage; door-to-imaging targets are measured in minutes.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Stroke · 2019doi:10.1161/STR.0000000000000211
New England Journal of Medicine · 2008doi:10.1056/NEJMoa0804656
American College of Radiology · 2024
