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Product:

Version 6

CAD4TB

Company HQ: 

's-Hertogenbosch, The Netherlands

Last Updated:

August 31st, 2020

CAD4TB is a software product that takes a single posterior-anterior chest radiograph as input, in the form of a DICOM image, and produces several outputs. Output includes a quality assessment of the input image, a heat map indicating possible areas of abnormalities, and an output score between 0 and 100 related to the likelihood the X-ray demonstrates abnormalities associated with tuberculosis (TB).

CAD4TB is mainly used as a triage/prioritization tool. Because of its ability to work offline and the main output is a score the product doesn't need skilled health care workers to determine which test needs to be done after the triage/screening according to the software. Based on the set threshold local staff can ask the screened person to submit sputum and run a GeneXpert test. After the triage, abnormal images from patients who were GeneXpert-negative can still be read by a skilled radiologist to determine what to do next (for a clinical diagnosis of TB and/or other diseases).

Certification

CE 0344 marked

Development Stage

On the market. TRL 9

Deployment

Online & offline

Intended Age Group

4+ years (regulatory approval)

Target Setting

Primary health centers, government/public sector, e.g. national TB program, private sector

Current Market

CAD4TB is in use in over 40 countries. A complete list can be found on the website: https://www.delft.care

Input

»» Can be used to read images from any kind of chest X-ray machine

»» Chest X-ray image format: DICOM

»» Chest X-ray type: posterior-anterior chest X-ray

»» Other requirements: product requires upload of an original image in the standard DICOM-format which contains appropriate DICOM metadata information in specific DICOM tags

JPG/PNG image format available upon request.

Output

The CAD4TB results consist of:

»» Heat map 

»» Probability score for TB


The output format is configurable making it fully compatible with existing infrastructure, such as PACS systems.

Server

Amazon Web Service (AWS) is used. In-country or on-premise servers are available upon request.

Integration

For version 6 it is possible to send the heatmap and abnormality score in a DICOM format to a picture archiving and communication system (PACS).

Software

CAD4TB 6 runs on Linux. Currently, Ubuntu LTS 18.04 is preferred.

Processing Time

Less than 20 seconds

Hardware

CAD4TB comes as a complete product and is installed on a mini computer called the CAD4TBbox.

Validation

Because of the variety of X-ray machines and populations on which the software has been validated, validation per X-ray machine is often not necessary. However, as an optional service, the developer can support with helping to set the threshold based on your settings and population. This includes sending a selection of normal and abnormal images to Delft. With these images, a ROC curve and table with threshold, sensitivity and specificity levels is given. Together with the customer, a decision can be made about the optimal threshold.

Data Sharing & Privacy

»» Server Location: Amazon Web Service is used for standard cloud servers which has multiple datacenters around the world. In very special cases Delft can set up a local or national server if required

»» No data is shared with the developer. As a company headquartered in the Netherlands, the developer follows the General Data Protection Regulation (GDPR) of the European Union. Each customer receives a Data Processing Agreement that provides clear insight on how their data is processed and used. The developer does not use the data for any other purpose than to provide the CAD4TB result for the customer, unless given explicit permission. Any data processed by CAD4TB remains the property of the customer.

»» Data is de-identified before it is sent to the server in order to make sure no personal information is sent across the internet.

Software Updates

»» Annual software updates

»» Updates are included in the price

»» No additional costs, as long as hardware permits. If improved hardware is required, Delft will charge the cost of the new hardware.

Price

»» CAD4TB is sold on a per use basis and is available offline and/or online. Bundle prices depend on volume and range from US$ 0.45 to US$ 0.95 depending on the volume (higher-volume purchases will cost less per unit)

»» Offline: Upfront cost for a CAD4TB box is US $ 6000 and is inclusive of shipment, remote support and two-year warranty on the hardware.

»» Online: Upfront cost for cloud service (for primary or secondary review and/or archiving purposes) is US $2 500 and entails the setup of the cloud server, the installation of the upload program which allows images to be sent compressed and de-identified if required, and remote support.

»» There is no pricing difference for public or private sector.

»» Prices can be further customized on a project basis depending on project objectives and goals.

Product Development Method

Supervised deep learning (CNN, RNN) and manual feature engineering

Training

The product was trained on 1 million chest X-rays from several countries.

Reference Standard

Human reader, culture and GeneXpert results

Publications

»» Over 40 scientific publications and references. A complete list of all publication related to CAD4TB can be found on https://www.delft.care/publications/

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