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
High pretest probability of PE → CTPA without D-dimer; start anticoagulation while awaiting imaging when bleeding risk allows.
Patients with a high clinical probability of pulmonary embolism (Wells or Geneva high tier) proceed directly to CT pulmonary angiography without D-dimer testing, since a negative D-dimer cannot safely exclude PE at high pretest odds.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
European Heart Journal · 2020doi:10.1093/eurheartj/ehz405
New England Journal of Medicine · 2006doi:10.1056/NEJMoa052367
JAMA · 2006doi:10.1001/jama.295.2.172