COMPANY
Koios Medical, Inc.
Healthcare technology company based in Chicago, United States
Founded 2012Chicago, United States
Clinical utility and economic value of AI tools in thyroid nodule stratification
Product: KOIOS DS Company: KOIOS Medical, Inc
Integrating Artificial Intelligence in Thyroid Nodule Management: Clinical Outcomes and Cost-Effectiveness Analysis
Journal of Clinical Utrasound, 2025
Abstract
Objective
The increasing incidence of thyroid nodules (TN) raises concerns about overdiagnosis and overtreatment. This study evaluates the clinical and economic impact of KOIOS, an FDA-approved artificial intelligence (AI) tool for the management of TN.
Methods
A retrospective analysis was conducted on 176 patients who underwent thyroid surgery between May 2022 and November 2024. Ultrasound images were evaluated independently by an expert and novice operators using the American College of Radiology Thyroid Imaging Reporting and Data System (ACR-TIRADS), while KOIOS provided AI-adapted risk stratification. Sensitivity, specificity, and Receiver-Operating Curve (ROC) analysis were performed. The incremental cost-effectiveness ratio (ICER) was defined based on the number of optimal care interventions (FNAB and thyroid surgery). Both deterministic and probabilistic sensitivity analyses were conducted to evaluate model robustness.
Results
KOIOS AI demonstrated similar diagnostic performance to the expert operator (AUC: 0.794, 95% CI: 0.718-0.871 vs. 0.784, 95% CI: 0.706-0.861; p = 0.754) and significantly outperformed the novice operator (AUC: 0.619, 95% CI: 0.526-0.711; p < 0.001). ICER analysis estimated the cost per additional optimal care decision at -€8,085.56, indicating KOIOS as a dominant and cost-saving strategy when considering a third-party payer perspective over a one-year horizon. Deterministic sensitivity analysis identified surgical costs as the main drivers of variability, while probabilistic analysis consistently favored KOIOS as the optimal strategy.
Conclusion
KOIOS AI is a cost-effective alternative, particularly in reducing overdiagnosis and overtreatment for benign TNs. Prospective, real-life studies are needed to validate these findings and explore long-term implications.