New Transparent-AI Manufacturers and Products Added to AI Central in December 2023

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ACR Data Science Institute’s AI Central had a busy month, adding new manufacturers to our AI Central PRO and Transparent-AI programs as well as eight new imaging AI products to the directory. 

New AI Central PRO Manufacturers and Transparent-AI Products 

A special welcome to our inaugural group of imaging AI manufacturers who joined our AI Central PRO and Transparent-AI programs: GE HealthCare, Siemens Healthineers, Therapixel and Whiterabbit.ai.

AI Central PRO allows manufacturers to add additional information to their manufacturer and product profiles on AI Central to explain how their products work in an effort to improve patient care and make it easier to learn more. This gives radiologists a better understanding of how a product can best support their patients and workflows through supplemental material about each product developed by the manufacturer.   

Transparent-AI is a new program designed to increase transparency in imaging AI and help end users have better informed discussions and selection criteria when making decisions about which algorithm might be most appropriate for their local target population. 

Transparent-AI consists of voluntarily provided data elements solicited from participating imaging AI manufacturers who currently have an FDA-cleared product in the U.S. market. Manufacturers who participate in this program will receive the Transparent-AI badge on their product listing.   

Below is a list of manufacturers who have joined both our AI Central PRO and Transparent-AI programs, including descriptions of their Transparent-AI products. 

GE HealthCare

Products participating in Transparent-AI: 

  • Liver ASSIST Virtual Parenchyma: A 3D Visualization software solution that helps the analysis of 3D X-ray angiography images of the liver. Its output is intended as an adjunct means to help visualize vasculature and identify arteries leading to the vicinity of hypervascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during the planning phase of embolization procedures. 
  • Critical Care Suite 2.0: Critical Care Suite is a computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization or triage in the PACS/workstation. Critical Care Suite is intended for notification only and does not provide diagnostic information beyond the notification. 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 adult-size patients. 
  • Critical Care Suite with Endotracheal Tube Positioning AI Algorithm: Critical Care Suite with the Endotracheal Tube Positioning AI algorithm produces an on-screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endotracheal tube tip and carina. This information is also transmitted to the radiologist for review. Intended users include licensed qualified healthcare professionals (HCPs) trained to independently place and/or assess endotracheal tube placement and radiologists. Critical Care Suite with the Endotracheal Tube Positioning AI Algorithm 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 healthcare professional. Critical Care Suite with the Endotracheal Tube Positioning Al Algorithm is indicated for adult-sized patients.
  • Critical Care Suite with Pneumothorax Detection AI Algorithm: Critical Care Suite with Pneumothorax Detection AI Algorithm is a computer-aided triage, notification and diagnostic device that analysis 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 aide during interpretation of radiographs. Intended users include qualified licensed healthcare professionals 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). 
  • Embo ASSIST AI: Embo ASSIST with Virtual Injection is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. It is not intended to be used during therapy delivery. The output includes segmented vasculature, and selective display of proximal vessel and distal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of Embo ASSIST AI prior to therapy delivery. 

Siemens Healthineers

Products participating in Transparent-AI: 

  • AI-RAD Companion Chest CT: AI-RAD Companion Chest CT is an image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, general practice in the evaluation and assessment of cardiovascular diseases.  

Therapixel

Products participating in Transparent-AI: 

  • MammoScreen®: MammoScreen® is an AI-based proficiency tool that helps radiologists interpret mammograms more accurately and faster. Working alongside radiologists, its uniquely actionable MammoScreen Score™ allows radiologists, at a glance, to quickly confirm what they suspect while providing the accuracy to detect what may have been missed. This allows radiologists to concentrate their energies on the questionable cases that require further scrutiny. With MammoScreen, even experienced radiologists improve their performance, feel more confident in their decision, and find more cancers. Our solution is subscription-based and vendor-neutral, easily fitting into existing infrastructure providing a non-intrusive zero-click workflow. MammoScreen evaluates both 2D and 3D screenings and is the only breast screening software that can incorporate priors into consideration. 

Whiterabbit.ai

Products participating in Transparent-AI: 

  • WRDensity: WRDensity is an AI-driven breast density software that assists radiologists in interpreting breast density to create uniformity of density assessment at the practice level. 

Manufacturers who joined Transparent-AI since our last update include: 

Aidoc

Products participating in Transparent-AI: 

  • Briefcase for aortic dissection (AD): BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of CT exams with contrast (CTA and CT with contrast) that include the chest in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection (AD) pathology 
  • Briefcase for PE triage: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of Pulmonary Embolism (PE) pathologies. 
  • Briefcase for Pneumothorax: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of Chest X-Ray images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect positive cases with Pneumothorax (Ptx) findings. 
  • BriefCase-RibFx: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest CTs (with or without contrast) images, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies. 
  • Briefcase- IFG: BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies. 

AIRS Medical

Products participating in Transparent-AI: 

  • SwiftMR: SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of brain, spine, knee, ankle, shoulder and hip MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for non-contrast enhanced MR images. 

Cortechs.ai

Products participating in Transparent-AI: 

  • NeuroQuant: NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric measurements may be compared to reference percentile data. 
  • OnQ Neuro: OnQ Neuro is a fully automated post-processing medical device software intended for analyzing and evaluating neurological MR image data. It is intended to provide automatic segmentation, quantification and reporting of derived image metrics. It is additionally intended to provide automatic fusion of derived parametric maps with anatomical MRI data. It is intended for use on brain tumors, which are known/confirmed to be pathologically diagnosed cancer. It is intended for comparison of derived image metrics from multiple time-points. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision. 

Qure.ai

Products participating in Transparent-AI: 

  • qER-Quant: The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is K211222 2 intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images. qER-Quant provides volumes from NCCT images acquired at a single time point and provides a table with comparative analysis for two or more images that were acquired on the same scanner with the same image acquisition protocol for the same individual at multiple time points. The qER-Quant software is indicated for use in the analysis of the following structures: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift. 
  • qER: qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. The device is intended to assist hospital networks and trained medical specialists in workflow triage by flagging the following suspected positive findings of pathologies in head CT images: intracranial hemorrhage, mass effect, midline shift and cranial fracture. qER uses an artificial intelligence algorithm to analyze images on a standalone cloud-based application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include non-diagnostic preview images that are meant for informational purposes only. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of the device are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. 
  • qXR-CTR: qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities. The system is suitable for adults ≥ 22 years of age. The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases. 
  • qXR-BT: The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest Xrays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image. 
  • qXR-PTX-PE: qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, qXR-PTX-PE does not send a proactive alert directly to the appropriately trained medical specialists. qXR-PTX-PE is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

New Imaging AI Products

Our AI Central directory has also been updated with eight new products. With this latest update, we see newly cleared FDA products designed for CT scans of the head and chest.

New products include: 

Developed by Aidoc Medical, Ltd.: 

Developed by Bering Ltd: 

  • BraveCX: BraveCX is a radiological computer-assisted triage and notification software that analyzes adult (≥18 years old) chest Xray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).  

Developed by Brainomix Limited: 

  • Brainomix 360 Triage Stroke: Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH). 

Developed by Clarius Mobile Health Corp.:

  • Clarius Bladder AI: Clarius Bladder AI is intended for semi-automatic non-invasive measurements of bladder volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and phased array scanners).  

Developed by Lunit Inc.:

  • Lunit INSIGHT DBT: Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible DBT systems.  

Developed by 4DMedical Limited:

  • CT Lung Ventilation Analysis Software (CT:V): CT: V software is a non-invasive image processing technology that measures volume changes from paired inspiration-expiration CTs to quantify and visualize regional and global ventilation.