Design verification testing which included confirming all labeling complies with 21CFR801 and all software requirements work as expected. QuantX is a computer-aided diagnosis (CADx) software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. Software can be used to mark calcified coronary lesions and allocate each lesion to one of several coronary arteries. DM-Density provides these numerical values for each breast as well as a density category to aid interpreting physicians in the assessment of breast tissue composition. These flags are viewed by the clinician in Bone Health and Fracture Liaison Service programs in the medical setting via a worklist application on their Picture Archiving and Communication System (PACS). Functionalities include: automatic segmentation and quantitative analysis of individual brain structures, quantitative comparison of each brain structure with normative data from a healthy population, and presentation of results for reporting that includes all numerical values as well as visualization of these results. A pivotal reader study which was a retrospective, fully crossed, multi-reader multi case (MRMC) study was conducted to validate the device. The first operating point showed a sensitivity of 96.74% and specificity of 93.17%. this device uses multivariate pattern recognition methods to perform characterization and classification of images. MaxQ-AI conducted a retrospective study to test the clinical performance of Accipiolx in processing non-contrast head CT cases with a high or low probability of ICH. Safety and performance of the device has been evaluated and verified in accordance with software specifications and applicable performance standards. 4. While the time to notification average of CotnaCT is 7.32 minutes. Functional verification testing and development validation were conducted to verify that the design output met the design input requirements. It is not a diagnostic aid. Dataset included a total of 652 lesions, 314 benign, and 338 malignant. FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. The NinesAI device underwent performance testing to verify the efficacy and safety of the machine learning algorithms. OsteoDetect-Unaided AUC .840, sensitivity .747, and specificity .889. Algorithm performance yielded good comparability to reader study results and met all prespecified acceptability thresholds. Image analysis software designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. For clinical validation the following algorithms underwent a scientific evaluation: Segmentation of heart, detection of coronary calcium, segmentation of aorta, detection of aortic landmarks, aorta diameter measurements, and threshold-based categorization of diameter measurements. CuraRad-ICH is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage. New artificial intelligence-powered technology may soon help reduce delays in diagnosing a collapsed lung, or pneumothorax, which is a serious condition that can be treated with quick intervention. QbCheck helps with the diagnosis and treatment of ADHD. QuantX (DEN270022), ClearView cCAD (K161959). Overall cmTraiage was able to demonstrate an AUC of .951 with a 95% CI of 0.937 to 0.964 on this dataset. Many research teams are experimenting with AI/ML-based healthcare applications. To date, FDA has cleared or approved several AI/ML-based SaMD. The Vitrea CT Lung Density Analysis software was designed, developed, and tested according to written procedures that included risk management. RESULTS Cross-checked and validated medical devices and algorithms Cross-checking and validation of all announcements resulted in a database with 64 AI/ML based, FDA-approved medical devices and algorithms. A total of 10 board-certified radiologists and a collection of 249 scans were involved in the reader study. AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing, and evaluating MR prostate images. The device has been validated in retrospective performance study on chest CT data. The FDA just granted clearance to a suite of algorithms that could help healthcare providers in the US more accurately screen for heart conditions during routine physical exams. The Zebra HealthMammo is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. DMDensity calculates percent breast density defined as the ratio of fibro-glandular tissue to total breast area estimates. This system was trained using a dataset of over four million images from 9,000 patients, and aims to assist cardiologists with rapid image analysis. ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, 2 independent of standard of care workflow. Ground truth for the presence/absence of distal radius fracture is defined as the majority opinion of at least 2 of 3 clinicians participating. Verification activity included unit, integration, and system level testing. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. Testing was conducting at the Mammogram-level, Breast-level and Finding-level. This performance was observed for both PA and LAT views across elderly status and post-surgical status, and it was observed on radiographs representative of OsteoDetect’s intended use. The device is intended to be used on neonates and infants, aged 0-12 months. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) CT angiographies of the head for large vessel occlusion (LVO). Read on for a summary of the most recent approvals to see the versatility of AI in the medical space. DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change. Send information on AI algorithms that are not listed and report missing information to. The final standalone dataset was composed of 888 CXR images from 2 clinical sites from the US and 2 clinical sites from the UK. Each user felt that the Vitrea CT Lung Density Analysis software enables the user to assess and quantify lung density. The VIDA|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. Broncholab successfully passed verification testing. Variability testing was also performed to demonstrate that EchoMD AutoEF performs acceptably with a variety of image clips and frames from the same patient. This system is designed to work alongside radiologists and help them make more accurate decisions, rather than to replace them. So far, only 26 have received FDA approval as of May 2019. Imagen performed a MRMC retrospective study to assess performance of OsteoDetect when used with concurrent reading to assist clinicians in detecting distal radius fractures during interpretation of PA and LAT radiographs of adult wrists. The AlphaPoint software has been verified and validated according to the company's design control process. A MRMC was performed to validate that the device conformed to the defined user needs and intended uses. Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. Results from the standalone study showed that Case-level sensitivity, lesion-level sensitivity, FP Rate in Non-Cancer Cases, and specificity met design specifications. “The FDA has only just begun to develop procedures to evaluate the safety of AI-based medical imaging algorithms. 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). VIz.AI conducted a retrospective study to assess the sensitivity and specificity of the image analysis algorithm and notification functionality of ContaCT against a ground truth as established by a neuroradiologist in the detection of large vessel occlusions (LVO) in the brain. Test data included data from healthy subjects, and patients with neurodegenerative diseases. A secondary endpoint measure was Briefcase's potential clinical benefit of worklist prioritization for true positive PE cases. The results indicated that ClearRead +Confirm is a useful adjunct for the interpretation of chest radiographs when looking for TLW. This technology was found to have less variability in analyzing left ventricular ejection fraction (EF) than most cardiologists in a study conducted with the Minneapolis Heart Institute. Ground truth for each case was determined by three US board certified orthopedic hand surgeons. PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. Sensitivity was 91.7% and specificity was 88.6%. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). Convenient summaries for each algorithm include model manufacturer, FDA product code, body area, modality, predicate devices, product testing and evaluation related to product performance, and clinical validation. For malignancy risk classification, bench testing was performed to ascertain the degree of concordance with trained interpreting physicians. Sensitivity and specificity exceeded the 80 % performance goal. All studies were reviewed by neuroradiologists to establish the Ground truth, each study was reviewed to determine if the image contained image features consistent with an LVO, and thus required further review. The data included a retrospective cohort of 835 anonymized 2D FFDM screening mammograms from the USA, UK, and Israel. The set was carefully selected to include data from multiple vendors and a series of representative scan settings. Verification and validation including risk mitigations have been executed with results demonstrating Hepatic VCAR met the design inputs and user needs with no unexpected results or risks. The test set for the white matter hyperintensitiy analysis included 45 3D T1w images. The Medical Futurist Institute (TMFI) pioneered the first open-access, online database of FDA-approved A.I.-based algorithms. HealthICH triage sensitivity is 94.74% and specificity is 92.54%. It displays time density curves, perfusion characteristics in perfusion and summary maps, as well as regions of interest and mirrored regions. BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. 3-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis. The truth is there was already a lot of innovative focus on developing AI medical solutions (whether effective or not), but lacked support from effective approval processes. The Medical Futurist Magazine Analysis of 360 newly tested cases collected from multiple sites across 17 US states. For detection accuracy, the AUC of the ROC is .965, sensitivity is 92.1% and specificity is 90.2%. A formal retrospective, non-interventional validation study was conducted using over 378 previously acquired studies. Caption Interpretation AutoEF was the subject of a pivotal clinical investigation to validate successful performance of the EF calculation in comparison to conventional EF calculation methods. NinesAI is a parallel workflow tool indicated for use by hospital networks and trained clinicians to identify images of specific patients to a radiologist, independent of standard of care workflow, to aid in prioritizing and performing the radiological review. iCAD performed various standalone testing for the device. ProFound AI V2.1 has been verified and validated according to iCAD's design control processes. Software provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. Verification, Validation and Performance Testing was completed. For clinical validation, the algorithms for vertebrae segmentation, vertebra height and vertebra density measurements underwent scientific evaluation. Another radiologist was used to break ties between the report and the reviewer. Design validation was performed in simulated use settings. The clinical study had 971 datasets from multiple makes and models of scanner for assessing the performance of the FerriSmart IQX module; assessing the bias and limits of agreement between FerriSmart and FerriScan measurements of LIC on multiple scanners; assessing the diagnostic performance of FerriSmart for predicting FerriScan LIC results above various clinically relevant LIC thresholds on multiple scanners. For the PE pathology, the software is only intended to be used on single-energy exams. The amount of US Food and Drug Administration (FDA) approvals of proprietary medical algorithms powered by artificial intelligence (AI) for image … Various laboratory testing was performed. The validation set was truthed by two US board certified neuro-radiologists. iReveal® by iCAD, Inc. (formerly M-Vu® by VuCOMP, Inc.) K132742. Ground truth for malignancy risk classification was determined by pathology or 1- year follow-up for cases that were not biopsied. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. ClearRead CT was found to decrease read times with and without outliers. Validation testing included standalone testing and performing a pivotal reader study to compare the clinical performance of radiologists using CAD detections and Certainty of Finding and Case Scores from the system to that of radiologists using DBT without CAD. StoneChecker underwent usage validation at two clinical sites in Oxford, UK and Beijing, China. Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. Subjects include healthy subjects, Alzheimer’s disease patients, multiple sclerosis patient, traumatic brain injury patients, and depression patients. Ground truth was determined by a review of a single radiologist and the radiology report. Resonance Health Analysis Service Pty Ltd. FerriSmart is intended to use for measurement of R2 and iron concentration in the liver from MRI scans. The validation data set was truthed by three US Board-Certified Radiologists. The difference from true locations in ClearRead Confirmn reads and unaided reads were not found to be statistically significant. The validation data set was truthed by three US Board-Certified Radiologists. Software testing was completed to ensure the new features operate according to defined requirements. Non-Interpretive Panel Call for Volunteers, Hackathon Testing ACR's Platform-Model Communication for AI. Quantib ND is a software application on top of Myrian. 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