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
Prefer US and non-contrast MRI in pregnancy; perform a clearly indicated CT when alternatives are inadequate — diagnostic delay harms both patients.
Ultrasound and MRI (without gadolinium) are the preferred modalities throughout pregnancy. Diagnostic X-ray and CT doses are generally below fetal harm thresholds, and a medically indicated study should never be withheld solely because of pregnancy — but a radiation-free alternative is preferred when diagnostically adequate.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Obstetrics & Gynecology · 2017doi:10.1097/AOG.0000000000002355
American College of Radiology · 2024