FDA Clears AI-Powered Thyroid Ultrasound Analysis System

TOPLINE:

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.

METHODOLOGY:

• The AI software uses single or multinodular thyroid ultrasound images in detecting nodules and is capable of automatically classifying the nodules in accordance with the American College of Radiology’s (ACR) Thyroid Imaging Reporting and Data System (TI-RADS).
• The system automatically generates a complete worksheet and after clinician review and approval, preliminary impressions are sent to radiology reporting systems.
• The features are designed to reduce reporting time as well as variation in delivery of care for thyroid ultrasound, the company reported.

TAKEAWAY:

• A multireader, multicase (MRMC) study included in the FDA submission demonstrated improvement in radiologist performance with the aid of the technology, See-Mode reported.
• The AI system can provide thyroid detection and diagnosis with a high level of automation, including automatic detection and characterization of thyroid nodules without the need for manual user input, allowing clinicians to review and adjust the AI outputs quickly before finalizing the report.
• The system allows for the streamlined reporting of follow-up thyroid studies, reducing the burden of the time-consuming task for radiologists.
• Due to existing Current Procedural Terminology codes pertaining to the use of AI for analysis of thyroid ultrasound, reimbursement opportunities are improved.

IN PRACTICE:

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:

See-Mode Technologies Press Release: “See-Mode Technologies Receives FDA Clearance for Thyroid Ultrasound AI Analysis and Reporting Software.”

LIMITATIONS:

The information was presented by the company in a press release.

DISCLOSURES:

Individual authors are employed by See-Mode Technologies.