See-Mode Technologies has announced 510(k) clearance from the U.S. Food and Drug Administration for software designed for thyroid ultrasound analysis and reporting.
See-Mode’s AI-powered solution is designed for reporting time and minimize variability in thyroid ultrasound care. The software automatically identifies nodules in both single and multinodular thyroid ultrasound images, classifying them according to the American College of Radiology's (ACR) TI-RADS system.
Current CPT codes related to AI-based thyroid ultrasound analysis offer increased reimbursement opportunities. It is the first FDA-cleared product for both detection and diagnosis (CADe/x) in thyroid ultrasound. Clinicians can quickly review and adjust the AI-generated results before finalizing the report.
The product also simplifies the reporting process for follow-up thyroid studies, tackling a major challenge and time-consuming task for radiologists.
See-Mode improved radiologist’s ability to localize and characterize nodules while increasing agreement on ACR TI-RADS levels, which enhanced the accuracy in distinguishing between benign and malignant thyroid nodules.
By bringing AI into routine clinical practice, it will reduce the reporting time and inter-operator variability that exists in thyroid ultrasound.
Source: https://www.prnewswire.com/news-releases/see-mode-technologies-receives-fda-clearance-for-thyroid-ultrasound-ai-analysis-and-reporting-software-302249938.html
