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: transvaginal US with quantitative β-hCG for any pregnant patient with pain or bleeding — ruptured ectopic remains a leading cause of first-trimester maternal death.
Pelvic pain or bleeding with a positive pregnancy test is an ectopic workup: transvaginal ultrasound correlated with quantitative β-hCG. An empty uterus above the discriminatory zone, or an adnexal mass with free fluid, drives urgent management.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Obstetrics & Gynecology · 2018doi:10.1097/AOG.0000000000002560
American College of Radiology · 2024