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FDA Clearance for Thyroid Ultrasound AI Analysis and Reporting Software

See-Mode Technologies, a global innovator in AI for ultrasound imaging, today announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their thyroid ultrasound analysis and reporting software.

The software detects nodules in single or multinodular thyroid ultrasound images, and automatically classifies each nodule in line with the American College of Radiology’s (ACR) TI-RADS rating systems. A complete worksheet is automatically generated and preliminary impressions are sent to radiology reporting systems after clinician review and approval. Existing CPT codes relevant to the use of AI for analysis of thyroid ultrasound also provide greater reimbursement opportunities.


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