Aidoc conducted a retrospective, blinded, multicenter, study with the BriefCase software to evaluate the software's performance in identifying head CTA images containing Large Vessel Occlusion (LVO) in 383 cases from 3 US-based clinical sites. By using this FDA-approved diagnostic tool, radiologists can better diagnose the severity of the arterial defect to improve patient outcomes. To demonstrate the performance of icobrain, endpoints were validated for accuracy and reproducibility. A total of 19 readers completed the study 111 breast MR images. Bay Labs received approval for their EchoMD AutoEF deep learning software last June. Software can be used to mark calcified coronary lesions and allocate each lesion to one of several coronary arteries. The algorithms … ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. Read on for a summary of the most recent approvals to see the versatility of AI in the medical space. Algorithm Approval Acceleration. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures. ... we need to make the function and application of algorithms transparent, and the FDA provides a useful model. Aidoc conducted a retrospective, blinded, multicenter, multinational study with BriefCase software with the primary endpoint to evaluate the software’s performance in identifying non contrast CT head images containing ICH findings in 1198 cases form 3 clinical sites. Viz.ai conducted a retrospective study assess the standalone performance of the image analysis algorithm and notification functionally of Viz ICH. The final standalone dataset was composed of 888 CXR images from 2 clinical sites from the US and 2 clinical sites from the UK. Approved by the FDA in September of last year, the ECG technology on the Apple Watch Series 4 uses electrodes to capture heart rhythm irregularities. Flow in Ascending Aorta (Partial) , Flow in Pulmonary Artery(Partial) , Pulmonary to Systemic Flow Ratio(Partial), Left Ventricle Volume(Partial), Cardiac Outputs(Partial). A secondary endpoint, is the software's clinical benefit of worklist prioritization for true positive CSF cases. For other details, clicking on the model will take you directly to the FDA summary. BriefCase is a radiological computer aided triage and notification software indicated foruse in the analysis of CTPA images. Typically expressed as a percentage, EF indicates how efficiently the heart pumps blood. The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. Results from internal verification and validation testing performed in accordance with Densitas' design control processes confirm that densitas densityai product specifications have been met. All performance results were superior to the ones achieved using the predicate device supporting substantial equivalence. BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. It performs quality control checks and generates parametric perfusion maps such as rCBV, CBF, MTT, and TTP and sends the maps to a PACS for subsequent viewing. Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. In a clinical study, QuantX use led to a 39% reduction in overlooked breast cancers and a 20% improvement in overall diagnostic improvement. Performance testing included protocols demonstrating: Clinical data (including professionally labeled regions-of-interest, T2- weighted anatomical data, and raw diffusion image series) were used for verification and validation of the diffusion analysis (diffusion signal normalization and restricted signal map conspicuity). The syngo.CT Lung CAD (VC30) is a CAD tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography examinations of the chest. However, 14 of those 26 have been approved in 2019 and the list … The technology leverages machine learning and image analysis with a large database of documented cases to help radiologists analyze MRIs. Broncholab can be used to support physicians in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). The software is intended to automate the current manual process of identifying, labeling and quantifying the segmentable brain structures identified on MR images. A Clinical study was executed to determine the effect of Koios DS for Breast on reader performance. The sensitivity and specificity of the HealthCXR was reported for two operating points, the first for equal sensitivity and specificity and the second operating point for a higher specificity. Structures identified on MR images and safety of AI-based medical imaging algorithms analyze head CT of. Rate in non-cancer cases, and segments and analyzes ASPECTS regions of interest ( ROI.. Of representative scan settings brainstat software Option for GE Signa MR Scanners ( K073167.... Allows radiologists to identify suspected ICH findings, the volumes were compared test-retest... Algorithm approval Acceleration qer uses an artificial intelligence algorithm to identify suspected findings development validation conducted. 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