Search Results

The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Ray cases with features suggestive of pneumoperitoneum in the medical care environment. HealthPPT analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthPPT is not intended to direct attention to anomalies other than pneumoperitoneum. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumoperitoneum or otherwise preclude clinical assessment of X-Ray cases.

The HealthPPT solution is a software product that automatically identifies suspected findings on chest x-rays (e.g. pneumoperitoneum) and notifies PACS/workstation of the presence of this critical finding in the scan. This notification allows for prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in prioritization and triage of radiological medical images only. The software is automatic and is capable of analyzing PA or AP chest x-rays. If a suspected finding is found in a scan, the alert is automatically sent to the PACS/workstation used by the radiologist or to a standalone desktop application in parallel with the ongoing standard of care. The PACS/workstation prioritizes and displays the study through its worklist interface. The ZebrAInsight standalone application includes a compressed preview image meant for informational purposes only and is not intended for diagnostic use. The HealthPPT device works in parallel to and in conjunction with the standard care of workflow. After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthPPT device performs the analysis of the study and returns a notification about the relevant pathology to the PACS/workstation for prioritization. The clinician is then able to review the study earlier than in standard of care workflow. The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of critical cases. The final diagnosis is provided by a radiologist after reviewing the scan itself. The following modules compose the HealthPPT software for Pneumoperitoneum: Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm. Pneumoperitoneum algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected finding suggestive of pneumoperitoneum. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent to the PACS/workstation for prioritization. Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.

The HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies.

HealthCCSng product is a software device that automatically estimates the coronary arterv calcium category from non-cardiac-gated adult CT scans. The product is aimed to leverage the high utilization of CT scans in the medical care environment (both inpatient and outpatient), including lung cancer screening programs, in order to automatically detect calcification in the coronary arteries of patients in an opportunistic manner. Zebra's HealthCCSng product analyzes cases using an artificial intelligence algorithm for the automated detection and estimation of coronary calcium and outputs a result for review by the radiologist. The device works in parallel to and in conjunction with the standard of care workflow. The final diagnosis is made by the radiologist after reviewing the scan independently of the software. The device is intended for use by the radiologists as a non-diagnostic analysis software in conjunction with additional patient information and professional judgment. HealthCCSng receives a non-cardiac-gated CT study from the storage application, Zebra's Imaging Analytics Platform (IMA). For each CT study received, the software shall validate there is at least one compliant series in which the entire heart is present, and perform an analysis. For each compliant study, the software shall output: 1.Estimated Coronary Calcium Detection, based on the measurement of calcium deposits in the coronary arteries. 2. A corresponding Estimated Coronary Calcium Detection Category, based on the Estimated Coronary Calcium measurement. The software output will include the following calcium categories: | Estimated Coronary Calcium<br>Detection | Corresponding Estimated Coronary Calcium<br>Detection Category | |-----------------------------------------|----------------------------------------------------------------| | 0-99 | Low | | 100-399 | Medium | | ≥400 | High | For patients in which calcium was detected, the user will be presented with representative images - all the slices containing the measured coronary calcifications (130 HU and above). On these images, the calcified areas will be annotated (with an option for the user to toggle on and off the annotation). The following modules compose the HealthCCSng software: Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view, etc.) to ensure compatibility for processing by the algorithm. HealthCCSng algorithm: Once a study has been validated, the algorithm analyzes the CT for analysis and quantification. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA. Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.

The Zebra Health.JOINT device is a software tool for 3D reconstruction of bones from a set of 2D radiographs. The device is intended for assisting clinicians in the preoperative planning of knee orthopedic surgical procedures. Zebra's HealthJOINT analyzes cases using an artificial intelligence algorithm for the 3D model reconstruction. In addition to the model, the software provides a list of anatomical landmarks with their position on the 3D model. The result is made available via a 3rd parties' software interface for further display and analysis of the 3D bone model. Clinical judgement and experience are required to properly use the models produced by this software.

Zebra's HealthJOINT device is a software product that uses an artificial intelligence algorithm to analyze X-ray scans. The HealthJOINT is indicated for the analysis of X-rays scans. The device receives a set of 2D radiographs and automatically provides a 3D model of the bones together with a list of anatomical landmarks with their position on the 3D model may be used by physicians for pre-operative planning of knee orthopedic surgeries. The HealthJoint supports 3D reconstructions of healthy bones, and osteoarthritis patients graded 1 to 4 based on the Kellgren-Lawrence grading system. The HealthJOINT device functions as a component that can be used by 3rd parties via an API to generate the 3D models and provides a list of anatomical landmarks with their position on the 3D model. The software communicates with the API only, and is not user-facing. The software does not recommend clinical decisions or treatment. The software is intended for use by clinicians in conjunction with additional patient information and professional judgment. The following modules compose the HealthJoint software: Data input and validation: performs validation of the input, X-ray DICOM images, assesses the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm. HealthJoint algorithm: Once the study has been validated the algorithm analyzes the AP (anteriorposterior) along with the LAT (lateral) knee X-ray study in order to provide 3D bone models and locations of anatomic landmarks. IMA Integration feature: provides the capability to post studies for processing, get the study analysis status and the results of successful study analysis via a Web API. Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the calling 3rd party via the Web API.

The Zebra HealthMammo is a passive notification-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. HealthMammo utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam-level. HealthMammo produces an exam-level output to a PACS/Workstation for flagging the suspicious case and allows worklist prioritization. MQSA-qualified interpreting physicians are responsible for reviewing each exam on a display approved for use in mammography according to the current standard of care. HealthMammo device is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the interpreting physician's worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. The HealthMammo device is intended for use with complete 2D FFDM mammography exams acquired using validated FFDM systems only.

Zebra's HealthMammo solution is a software product that automatically analyzes 2D FFDM screening mammograms and notifies PACS/workstation of the presence of suspicious findings in the scan. This passive-notification allows for worklist prioritization of the specific scan and assists clinicians in viewing prioritized scans before others. The device aim is to aid in prioritization and triage of radiological medical images only. It is a software tool for MQSA interpreting physicians reading mammograms and does not replace complete evaluation according to the standard of care. The Zebra's HealthMammo device works in parallel to and in conjunction with the standard care of workflow. After a mammogram has been performed, a copy of the study is automatically retrieved and processed by the HealthMammo device. The device performs the analysis of the study and returns a notification about suspected finding to the PACS/workstation which flags it through the worklist interface or alternatively, the Zebra Worklist will notify the user through a desktop application. The clinician is then able to review the study earlier than in standard of care workflow. The primary benefit of the product is the ability to reduce the time it takes to alert physicians to the presence of a suspicious finding. The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of suspicious cases. The final diagnosis is provided by a clinician after reviewing the scan itself. The following modules compose the HealthMammo software: Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm. HealthMammo algorithm: Once a study has been validated, the algorithm analyzes the 2D FFDM screening mammogram for detection of suspected findings. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent to the PACS/workstation for prioritization. Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.

HealthVCF is a passive notification for prioritization-only, parallel-workflow software tool used by clinicians to prioritize specific patients within the standard-of-care bone health setting for suspected vertebral compression fractures. HealthVCF uses an artificial intelligence algorithm to analyze chest and abdominal CT scans and flags those that are suggestive of the presence of at least one vertebral compression at the exam level. 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). HealthVCF does not send a proactive alert directly to the user. Health VCF does not provide diagnostic information beyond triage and prioritization, it does not remove cases from the radiology worklist, and should not be used in place of full patient evaluation, or relied upon to make or confirm diagnosis.

Zebra's HealthVCF solution is a software product that automatically identifies suspected findings suggestive of vertebral compression fractures on chest and abdominal CT scans and provides a passive notification to the workstation of the presence of this finding in the scan. This notification is received by the standalone desktop Zebra Worklist application which flags the identified scan and assists clinicians engaged in bone-health management in viewing the scan ahead of others. The device aim is to aid in prioritization and triage of radiological medical images only and does not provide diagnostic information beyond triage. The software uses an artificial intelligence algorithm to automatically analyze chest and abdominal CT scans. If a suspected vertebral compression fracture is found in a scan, the alert is automatically sent to the Zebra Worklist application on the workstation used by the bone-health clinician in parallel with the ongoing standard of care within the bone health setting. The standard of care radiology workflow (i.e. reviewing and reporting the findings that initiated the request for CT) continues unaffected by the parallel workflow of the bone health program. For clarity, the HealthVCF device does not flag/prioritize cases within this radiology workflow. The standalone desktop application, Zebra Worklist, includes three sagittal preview images meant for informational purposes only and is not intended for diagnostic use. The Zebra Worklist presents all cases processed by the algorithm, and flags those with a suspected finding. Zebra's HealthVCF device works in parallel to and in conjunction with the standard care of workflow within bone health programs, and completely independent of the standard of care workflow within the radiology department. After a chest or abdominal CT scan has been performed, a copy of the study is automatically retrieved and processed by the HealthVCF device. The device performs the analysis of the study and returns a notification about a suspected vertebral compression fractures to the Zebra Worklist to notify the clinicians in Bone Health and Fracture Prevention Programs reviewing the chest and abdominal CTs for at-risk patients. The clinician is then able to review the study earlier and recall the patient for further evaluation. The primary benefit of the product is the ability to reduce the time it takes to alert physicians to the presence of a finding such as a vertebral compression fracture. The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of cases in bone health and fracture prevention programs. The final diagnosis is provided by a clinician after reviewing the scan itself. The following modules compose the HealthVCF software: Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm. HealthVCF algorithm: Once a study has been validated, the algorithm analyzes the chest and abdominal CT scans for detection of suspected finding suggestive of vertebral compression fracture. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent to Zebra Worklist application for triaging. Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.

The Zebra Head CT triage device is a software workflow tool designed to aid the clinical assessment of adult non-contrast head CT cases with features suggestive of intracranial hemorrhage in the medical care environment. HealthICH analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthICH is not intended to direct attention to specific portions of an image or to anomalies other than intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.

Zebra's HealthICH solution is a software product that automatically identifies suspected finding suggestive of Intracranial Hemorrhage and notifies the PACS/workstation of the presence of this critical finding in the scan. This notification allows for worklist prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in the prioritization and triage of radiological medical images only. Zebra's HealthICH Triage Device uses an artificial intelligence algorithm to analyze CT scans. The HealthICH is indicated for the analysis of non-contrast head CT scans. The algorithm output does not include an image and therefore it does not mark, highlight or direct users' attention to a specific location on the original CT scan. The Zebra's HealthICH device works in parallel to and in conjunction with the standard of care workflow. After a head CT scan has been performed, a copy of the study is automatically retrieved and processed by the HealthICH device. The device performs the analysis of the study and return a notification about a suspected finding suggestive of Intracranial Hemorrhage to the PACS/workstation which prioritizes it through its worklist interface. The clinician is then able to review the study earlier than in standard of care workflow. The primary benefit of the product is the ability to reduce the time it takes to notify physician to the presence of a critical finding such as suspected Intracranial Hemorrhage in the head CT scan. The software does not recommend treatment or provide a diagnosis. It is designed as tool to assist the medical staff and hospital networks in workflow triaging by highlighting and prioritizing studies containing suspected findings. The final diagnosis is provided by a radiologist or other qualified physician after examining the original scan as determined by the clinical standard of care. The software is intended for use by radiologists and other qualified medical staff who read head CT scans on a regular basis The following modules compose the HealthICH software: Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm. HealthICH algorithm: Once a study has been validated, the algorithm analyzes the head CT for identification of suspected finding suggestive of intracranial hemorrhage. IMA Integration feature: HealthICH interacts with users through the PACS/workstation via the Zebra Imaging Analytics platform (IMA). It does not have a Graphical User Interface (GUI). The HealthICH sends the results of the study analysis to the Zebra Imaging Analytics Platform, which then distributes the HealthICH results to the PACS/workstation for prioritization Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the Zebra Imaging Analytics Platform

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. The software can be used to generate reports of the total risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The HealthCCS Device analyses pre-existing heart or chest ECG-Gated Triggered CT scans. The Device is indicated for use only on patients whose age at the CT scan was taken, was above 20 years old. This device generates a 4-category Agatston-equivalent risk score, and the patient management, especially for the patient with the score from 0-10, will depend on the physician's own judgment. It may require further testing to evaluate the appropriate clinical management.

The HealthCCS Device is an automatic non-invasive post processing tool that uses cardiac CT images to identify and quantify calcification in the coronary arteries, known to be a risk factor for coronary disease. HealthCCS Device quantifies calcification on non-contrast cardiac computed tomography (CT) scans. HealthCCS Device calculates the amount of identified calcification and reports the risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment.