{"product_name":"Thyroid Ultrasound AI","company_name":"See-Mode Technologies","product_url":"https://www.see-mode.com/thyroid-ultrasound-ai","company_url":"https://www.see-mode.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0166","summary":"See-Mode Technologies' Thyroid Ultrasound AI is an FDA-cleared software that automates the detection and classification of thyroid nodules, streamlining reporting and enhancing diagnostic accuracy.","description":"See-Mode Technologies' Thyroid Ultrasound AI is an FDA-cleared software solution that automates the detection and classification of thyroid nodules in ultrasound images. It aligns with the American College of Radiology's (ACR) TI-RADS rating system, generating complete worksheets and preliminary impressions for radiologists. The software aims to reduce reporting time and inter-operator variability, improving diagnostic efficiency and accuracy. It also facilitates easy comparison between previous and new images, aiding in the assessment of nodule changes over time. The product is the first FDA-cleared device for both detection and diagnosis (CADe/x) of thyroid ultrasound, offering a high level of automation without manual user input. Clinicians can review and amend AI outputs before finalizing reports, streamlining the reporting of follow-up thyroid studies. A multi-reader multi-case (MRMC) study demonstrated that See-Mode enhanced radiologists' performance in nodule localization, characterization, and ACR TI-RADS level agreement, leading to improved differentiation between benign and malignant thyroid nodules.","categories":["clinical Care","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","radiology","healthcare Software Solutions","healthcare It","medical Device","regulatory Compliance","Clinical","Diagnostic Imaging","Artificial Intelligence","Medical Imaging","Radiology","Ultrasound Imaging","Medical Software","Healthcare It","Medical Devices","Regulatory Compliance"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Radiologists","Sonographers","Healthcare Administrators","Medical Imaging Professionals"],"specialties":["Endocrinology","Radiology","Oncology","Internal Medicine","Family Medicine","Otolaryngology","Surgery","Pathology","Nuclear Medicine","Preventive Medicine","Geriatrics","Pediatrics","Obstetrics And Gynecology","Emergency Medicine","Orthopedics","Neurology","Cardiology","Pulmonology","Gastroenterology","Nephrology"],"regions_available":["United States","Canada","Australia","New Zealand","Singapore"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["Australia","Singapore","United States","Canada","New Zealand"],"company_founding":"2018","deployment_model":["SaaS","on_prem"],"os_platforms":["Web","Windows"],"features":["Automatic detection and characterization of thyroid nodules","Alignment with ACR TI-RADS rating system","Generation of standardized ultrasound worksheets","Pre-population of radiologist report templates","Facilitation of follow-up examinations with change detection","Reduction of reporting time and inter-operator variability"],"optional_modules":[],"integrations":["PACS","RIS","Radiology reporting systems"],"data_standards":["DICOM","TI-RADS"],"api_available":"unknown","system_requirements":"Web browser; Windows OS for on-prem deployment","compliance":["FDA 510(k) clearance","CE Mark","HIPAA","GDPR"],"certifications":["FDA 510(k)","CE Mark"],"security_features":["Encrypted connections (TLS)","Role-based access controls","Audit logging"],"privacy_features":["Customer portal consent management","Data transfer notifications (EU→US disclosures)"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0166","slug":"thyroid-ultrasound-ai","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/thyroid-ultrasound-ai.json"}}