FDA Clears AI-Powered Software for Thyroid Ultrasound

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Providing automated TI-RADS classifications and worksheets, the new AI-enabled software may facilitate improved efficiency with thyroid ultrasound exams.

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.

FDA Clears AI-Powered Software for Thyroid Ultrasound

The newly FDA-cleared AI software from See-Mode Technologies for thyroid ultrasound exams reportedly provides automated TI-RADS classification of thyroid nodules. (Image courtesy of Adobe Stock.)

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.

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