Emerging AI Software Gets FDA Clearance for Diagnosing Breast and Thyroid Cancer

Koios DS, an artificial intelligence (AI)-based software platform that reportedly improves the accuracy and efficiency of diagnosing breast and thyroid cancer, recently garnered clearance from the Food and Drug Administration (FDA), according to the software manufacturer Koios Medical.

A recent multicenter retrospective review involving the assessment of 900 breast lesions showed that the addition of Koios DS Breast to ultrasound imaging improved correct BI-RADS classification of sonographic breast lesions by 14 of the 15 physicians participating in the study. 

For thyroid cancer, Koios Medical reported a 14 percent increase in detection rates with its Thyroid DS platform and more than a 35 percent reduction in false positive biopsy orders. The company also noted a greater than 50 percent reduction in interpretation variability.

Built with ultrasound data from a worldwide, 48-site network, the AI-generated findings with Koios DS are directly aligned with the BI-RADS and TI-RADS rating systems from the American College of Radiology, according to Koios Medical. The company added that the software is also aligned with the American Thyroid Association’s system for tissue classification and scoring. 

“ … This novel software demonstrates that (by) using AI for decision support, physicians can make clinically meaningful shifts in performance, improving interpretation efficacy and diagnostic performance, improving sensitivity and reducing false positives,” noted Lev Barinov, VP of clinical excellence and product management at Koios Medical. 

On the reimbursement front, Koios Medical pointed to new CPT Category 3 codes from the American Medical Association that clinicians may employ to bill for use of the Koios DS software in interpreting, classifying and reporting findings from traditional ultrasound examinations.