FDA Clears AI-Powered Software for Thyroid Ultrasound

The Food and Drug Administration (FDA) has granted 510(k) clearance for new AI-powered software geared toward thyroid ultrasound exams.

See-Mode Technologies, the developer of the software, said the software may help standardize assessment of thyroid ultrasound exams through automated TI-RADS classification of thyroid nodules. The company noted that results from a multi-reader, multi-case study demonstrated enhanced localization and characterization of thyroid nodules with adjunctive use of the AI software.

Facilitating workflow efficiency, the software also generates automated worksheets and reportedly streamlines reporting on follow-up thyroid studies, according to See-Mode Technologies.

“By bringing AI into routine clinical practice, we aim to reduce the reporting time and inter-operator variability that exists in thyroid ultrasound,” noted Milad Mohammadzadeh, a co-founder of See-Mode Technologies.

The company added that existing CPT codes for adjunctive AI interpretation of thyroid ultrasound may be applied for use of the See-Mode Technologies software.