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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
Unknown-onset stroke still gets emergent imaging — MRI mismatch or CT perfusion can qualify patients for reperfusion therapy.
Patients who wake with stroke symptoms have an unknown onset time, but advanced imaging can substitute for the clock: DWI-FLAIR mismatch selects thrombolysis candidates (WAKE-UP), and perfusion mismatch extends thrombectomy eligibility to 24 hours (DAWN).
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
New England Journal of Medicine · 2018doi:10.1056/NEJMoa1804355
New England Journal of Medicine · 2018doi:10.1056/NEJMoa1706442
Stroke · 2019doi:10.1161/STR.0000000000000211
