From: Clinical Application of Artificial Intelligence in Ultrasound Imaging for Oncology
| No. | Product name (company) | Subspeciality | Description | Regulatory certification | On market since | |
|---|---|---|---|---|---|---|
| CE | FDA | |||||
| 1 | LVivo Toolbox - Cardiac (DiA Imaging Analysis) | Cardiac | An AI echocardiographic analysis solution that provides objective echocardiographic image analysis aimed at reducing the challenges associated with manually capturing and visually analyzing ultrasound images | Certified, Class IIa, MDD | 510(k) cleared, Class II | 2013 |
| 2 | QVCAD (QView Medical) | Breast | An ANN-based system used as an adjunct to radiologists conducting breast screening exams for women who have negative mammogram results but dense breast tissue and therefore undergo 3D breast ultrasound (ABUS) | Certified, Class unknown | PMA approved, Class III | 09-2016 |
| 3 | AmCAD-UTⓇ (AmCad BioMed) | Head and neck | An AI solution that quantifies and visualizes ultrasound image features to help physicians make informed decisions | Certified, Class IIa, MDD | 510(k) cleared, Class II | 2017 |
| 4 | EchoGo Core (Ultromics) | Cardiac | An automated solution for cardiovascular findings to calculate ejection fraction, global longitudinal strain, and left ventricular volume | Certified, Class I, MDD | 510(k) cleared, Class II | 11-2019 |
| 5 | EchoGo Pro (Ultromics) | Cardiac | An outcome-based AI system to predict coronary artery disease | Certified, Class I, MDD | 510(k) cleared, Class II | 03-2020 |
| 6 | LVivo Bladder (DiA Imaging Analysis) | Bladder | A solution that transforms any on-premise ultrasound device into an AI-powered bladder scanner to accurately measure bladder capacity with a single click | Certified, Class IIa, MDD | 510(k) cleared, Class II | 06-2020 |
| 7 | TRACE4OC (DeepTrace Technologies Srl) | Ovary | A decision support system based on radiomics and machine learning to predict the malignant risk of ovarian mass from transvaginal ultrasonography and serum CA-125 levels | Certified, Class I, MDD | - | 05-2021 |
| 8 | Koios DS (Koios Medical, Inc) | Breast and thyroid | An AI-based software application designed to help trained readers analyze breast and thyroid ultrasound images | Certified, Class IIb, MDR | 510(k) cleared, Class II | 12-2021 |
| 9 | Ligence Heart (Ligence) | Cardiac | A platform that reads DICOM format data, recognizes image views and cardiac cycles, performs measurements, and generates reports based on the findings | Certified, Class IIa, MDR | - | 04-2022 |
| 10 | Us2.v1 (Us2.AI) | Cardiac | A machine learning-based solution that analyzes and interprets echocardiogram and ultrasound images of the heart to generate patient reports and is available on mobile, on-premises, and cloud-based platforms | Certified, Class IIb, MDR | 510(k) cleared, Class II | 06-2022 |
