FDA Clears AI-Powered Thyroid Ultrasound Analysis System

The US Food and Drug Administration (FDA) has issued 510(k) clearance to See-Mode Technologies for their AI-based thyroid ultrasound analysis and reporting software. While various AI tools for the evaluation of thyroid nodules have received FDA approval, See-Mode reports that their technology is the first FDA-cleared product providing detection as well as diagnosis for thyroid ultrasound. With thyroid nodules commonly detected as incidental findings on CT or MRI of the neck and chest, AI has become increasingly valuable in providing significantly higher level of interpretation.

In the MRMC study, "we observed that See-Mode enhanced the performance of radiologists in nodule localization, characterization, and ACR TI-RADS level agreement, leading to improved differentiation between benign and malignant thyroid nodules," said See-Mode co-founder Sadaf Monajemi in a press statement on the FDA clearance. "By bringing AI into routine clinical practice, we aim to reduce the reporting time and interoperator variability that exists in thyroid ultrasound," said co-founder Milad Mohammadzadeh.

Source: MEDspace