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Product:

CAD4TB

Version 8

Company HQ: 

Waterstraat 20, 5211JD s'Hertogenbosch, the Netherlands

Download Product Profile

Last Updated:

23 January 2023

CAD4TB (Computer-Aided Detection for Tuberculosis) is a state-of-the-art medical software, used to automatically analyse Chest X-ray images that come from a digital X-ray system. It is the first AI software that was available to TB programmes and in use clinically in 85 countries. It's CE certified since 2015 and intended for use on individuals ages 4+. The CAD4TB software takes a single frontal chest radiograph (PA) as input, in the form of a DICOM image, and produces several outputs after quality assessment of the image:
-TB score [0-100] related to the likelihood of the CXR image presenting abnormalities
- Heatmap indicating the possible areas with abnormalities associated with TB.
The above refer to our current version (v7). In the our coming version (v8), the following outputs have been added
- Abnormality score [0-100] related to the likelihood of a chest x-ray image presenting lung abnormalities
- Cardiothoracic ratio that helps assess the presence of Cardiomegaly.

Certification

v7: CE certified / v8: pending CE receipt

For v8: Delft have successfully conducted the CE certification audit and are now pending the actual certificate which will be issued from TUV NORD CERT GmbH (CE 0044) at the beginning of 2025. Until then, all projects are working with v7 which is CE certified from ages 4 and above.

Development Stage

On the Market

Deployment

Online & Offline

Intended Age Group

CE certified from 4 ages and above (v7)

Target Setting

Our CAD4TB has been effectively been used in many different settings and occasions including installations in private and public clinics and hospitals, active case finding, prison screening as well as used for the National Prevalence Survey of several countries

Current Market

Our CAD4TB is currently deployed in over 85 countries (clinically used, specifically in TB projects) and has impacted more than 32 million people

Input

Can be used to read images from any chest X-ray machine and model
Chest X-ray image format: DICOM, PNG, JPEG.
Chest X-ray type: PA (Posterior-Anterior) CXR from stationary, portable, and ultra-portable X-ray systems.

Output

Output consists of:

  • Heat map 

  • Dichotomous output indicating whether TB is likely present or absent 

  • Probability score for TB

  • Dichotomous output for general lung abnormality

  • Abnormality score for general lung abnormality


The default threshold is set at 60, however Delft provides (at their cost) the option of a Verification study to optimise it as per the countries population and neededs. CAD4TB has also the Dynamic threshold which gives a threshold recommedation taking into account also the available confirmatory tests.


Results are provided in a structured report. In the CAD4TB platform (a workflow platform that enables digitized TB screening data management - part of the CAD4TB solution) there is a Patient report module where all scores can be viewed.


Lung abnormalities included in the TB Score: Abscess, Air fluid level, Atelectasis, Bronchiectasis, Calcification, Cavity, Consolidation, Fibrosis, Loculated pleural effusion, Lymphadenopathy, Opacity, Pleural effusion, Prominence in hilar region, Tracheal shift 


Additional findings reported by the product: Algorithm does not specificy abnormalities. A general lung abnormality score is given featuring  Abscess, Air fluid level, Atelectasis, Bronchiectasis, Calcification, Cavity, Consolidation, Fibrosis, Loculated pleural effusion, Lymphadenopathy, Mass, Nodule, Opacity, Pleural effusion, Pneumothorax, Prominence in hilar region, Tracheal shift amongst others.

Hardware

The CAD4TB software is available in a completely offline solution where the AI is installed in a NUC mini-computer called CAD4TBbox. The hardware requirements are dual core processor with a minimun 8 GB RAM memory.

Server

Operating system requirements: 64-bit Ubuntu 20.04 or newer. Hardware requirements: dual core processor with a minimun of 8 GB RAM memory

Integration with X-ray Systems

Integration with PACS and Legacy Systems

The CAD4TB can be intergrated with any digital X-ray system that provided a DICOM Image as an output. There is no brand/model excluded as long as the DICOM protocol is followed.

CAD4TB can be integrated with any PACS system

Software

The CAD4TB solution is deployed as a Docket on a Linux machine (64-bit Ubuntu 20.04 or newer).

Processing Time

The output of CAD4TB software is available in less than 5 seconds.

Data Sharing & Privacy

As a European company, Delft imaging adheres to the GDPR regulations. This means that it has an agreement (called the DPA) that is intended to provide insight and transparency to those organizations supported with CAD4TB, so they are aware of how the company processes data safely and securely, and never misuses it.

Software Updates

Provide annual software updated and take care of patches resolution when ever required.

Price

The CAD4TB solution requires the purchase of the following components (the below referred prices are unit prices):

-Software (2 different options available):
Option 1: CAD4TB perpetual license (including unlimited readings/images and 1-year initial warranty) : USD 8.975,00
Option 2: CAD4TB 3-year license including 3-years service and maintenance: USD 8.552,00

-Hardware device (required for either of the software options):
- CAD4TBbox (allows the offline usage of the CAD4TB software): USD 2.750,00

-Training & installation (required per unit): USD 1.064,00

-Warranty extensions (advised when choosing for the Option 1 (CAD4TB perpetual license):
Option 1: CAD4TB 1-Year Service and Maintenance: USD 3.167,00
Option 2: CAD4TB 3-year Service and Maintenance: USD 9.500,00

Product Development Method

In the hardware part, Delft developed the CAD4TB-battery powered offline solution that ensures the automous operation of the solution for more than 6 hours. In the software part, Delft developed the coming version (v8) and numerous updates in both the software as well as the CAD4TBplatform.

Training

The software was trained on 1.000.000 X-rays (4 years old and above) from several countries and continents

Reference Standard

Delft use bacteriological reference for training the TB model. For the abnormality model, they use the radiologicial reference (human expert reader)

Publications

CAD4TB has been validated in over 110 scientific, clinical, and economic publications. A complete list of all publications related to CAD4TB can be found on https://www.delft.care/publications/

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© 2023 Stop TB Partnership and FIND

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