ACR Data Science Institute AI Central has been updated with seven new products. With this latest update, we see a few newly cleared FDA products designed for medical imaging of the heart.
New products include:
Neurophet AQUA Overview
- Developed and sold by: NEUROPHET, Inc.
- Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. Volumetric data may be compared to reference percentile data.
Critical Care Suite with Pneumothorax Detection AI Algorithm Overview
- Developed and sold by: GE Medical Systems
- Critical Care Suite with Pneumothorax Detection AI Algorithm is a computer-aided triage, notification, and diagnostic device that analyzes frontal chest X-ray images for the presence of a pneumothorax. Critical Care Suite identifies and highlights images with a pneumothorax to enable case prioritization or triage and assist as a concurrent reading aid during interpretation of radiographs. Intended users include qualified independently licensed healthcare professionals (HCPs) trained to independently assess the presence of pneumothoraxes in radiographic images and radiologists. Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the X-ray image by a qualified physician. Critical Care Suite is indicated for adults and Transitional Adolescents (18 to <22 years old but treated like adults).
Genius AI Detection 2.0 with CC-MLO Correlation Overview
- Developed and sold by: Hologic, Inc
- Genius AI Detection is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. The device intends to aid in the interpretation of digital breast tomosynthesis exams in a concurrent fashion, where the interpreting physician confirms or dismisses the findings during the reading of the exam.
ADAS 3D Overview
- Developed and sold by: Galgo Medical S.L
- ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease. ADAS 3D is indicated for patients with myocardial scar produced by ischemic or non-ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D. ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians) for the calculation, quantification and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making. The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.
Autoplaque 3.0 Overview
- Developed and sold by: Cedars-Sinai Medical Center
- Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present. Autoplaque must be installed on a suitable commercial computer platform. It is the user’s responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
- Developed and sold by: Cardio Flow Design Inc.
- The iTFlow software will be utilized in situations where visualization of blood flow in a heart and its major vessels are required for a cardiac diagnosis. iTFlow allows for the viewing, post-processing, and the quantitative evaluation of cardiovascular MRI data (in DIRECTOR-compliant format) It enables: - The import of DICOM-compliant MR Images. - The support of a clinical diagnosis by the quantitative analysis of the imported images. - Quantitative measurement of the size, area, blood flow, volume and mass of the heart and adjacent vessels. -Advanced correction options such as offset correction, background phase correction, and anti-aliasing. -Data visualization as a graph or output as an image or numerical data. iTFlow software will assist clinicians with proper training in cardiac treatment decision making and in providing a conclusive diagnosis for patients. It is intended to analyze cardiovascular MRI image data, that are acquired via electrocardiogram gated acquisition, gradient echo cine sequence, and phase contrast time-resolved multi-slice sequence, without any-contrast medium for MR angiography. Patient populations are not restricted.
SubtleMR (2.3x) Overview
- Developed and sold by: Subtle Medical, Inc.
- SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increase image sharpness for head MRI.
About AI Central: The AI Central database is intended to provide easy-to-access, detailed information regarding FDA cleared AI medical products related to radiology and other imaging domains and is frequently updated with new products and features. AI Central’s editorial board and staff continuously review data from FDA public facing documents, vendor information and physician feedback to provide users with up-to-date information to help make appropriate purchasing decisions.