FDA Clears Thyroid Ultrasound AI Analysis and Reporting Software

See-Mode Technologies announced FDA 510(k) clearance for its thyroid ultrasound analysis and reporting software.

The solution aims to reduce reporting time and variation in delivery of care for thyroid ultrasound. 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.

This is reportedly the first FDA-cleared product for both detection and diagnosis (CADe/x) of thyroid ultrasound. See-Mode differentiates its thyroid product with the level of automation that it offers, including automatic detection and characterization of thyroid nodules without manual user input, while enabling the clinicians to review and amend the AI outputs quickly before finalizing the report. The product also streamlines reporting of follow-up thyroid studies, addressing a significant pain point and time-consuming task for radiologists.

Dr Sadaf Monajemi, Co-founder of See-Mode, stated, “The results of a multi-reader multi-case (MRMC) study, that formed part of the FDA submission, showed improvement in radiologist performance with the aid of See-Mode. 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.”

Dr Milad Mohammadzadeh, Co-founder of See-Mode, added, “We are proud to receive FDA clearance for our thyroid ultrasound solution. By bringing AI into routine clinical practice, we aim to reduce the reporting time and inter-operator variability that exists in thyroid ultrasound.”