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Fujifilm’s portable X-ray system “FDR Xair System” obtains recommendation from the Stop TB Partnership as an X-ray device for tuberculosis screening

News Release

September 27, 2021

This news release is issued by FUJIFILM Corporation in Japan.
Fujifilm makes no representation that products on this news release are commercially available in all countries and regions. Approved uses of products vary by country and region.
Specifications and appearance of products are subject to change without notice.

TOKYO, September 27, 2021 – FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) is pleased to announce that the company’s “FDR Xair System,” which combines the portable X-ray unit “FDR Xair” and the digital X-ray diagnostic imaging device (Cassette DR) “FDR D-EVO II”, has been newly added to the Diagnostics Catalog of medical devices as a recommended chest X-ray system for tuberculosis (TB) diagnosis. The Catalog is issued by the Global Drug Facility (GDF)*1 under the “Stop TB Partnership*2” in collaboration with the World Health Organization (WHO). The GDF is an organization that strives to build a sustainable procurement and supply system for quality-assured TB treatments and diagnostics in emerging countries and other countries around the world. Fujifilm will supply the FDR Xair System to public medical institutions, NGOs and NPOs involved in TB eradication through the GDF.

The addition of the FDR Xair System to the Diagnostics Catalog has been carried out by the United Nations Office for Project Services (UNOPS)*3.

TB is one of the world’s three major infectious diseases*4 that affects over 10 million people each year and killed 1.4 million people in 2019 globally. TB patients in developing countries in Africa, Southeast Asia, and other regions account for approximately 90% of the total number of cases worldwide*5. Its strong transmissibility and heavy medical costs have cast a serious impact on the social and economic activities of such countries. There is a gap between the number of TB cases reported and the number of actual cases. It is said that some three million TB patients go undiagnosed each year, highlighting the importance of broad-based TB screening.

The FDR Xair System attracted attention from national leaders and health ministers of numerous countries as an X-ray device for TB screening for emerging countries when it was displayed in the Japan-Africa Business Forum, held alongside the seventh Tokyo International Conference on African Development (TICAD7) in Yokohama in August 2019. Since then, verification tests for the FDR Xair system’s application to TB screening have been held, including the verification tests conducted through Stop TB Partnership’s TB Reach program*6, in countries including Pakistan, Zambia, Vietnam and Azerbaijan. In these verification tests, the FDR Xair System was used to carry out TB screening in communities with underdeveloped electric infrastructures, taking advantage of the system’s portability and advanced operability thanks to its lightweight body and the use of a built-in battery. Results verified the effectiveness of the FDR Xair System for TB screening, leading to the Stop TB Partnership’s endorsement as a means of TB screening.

Fujifilm assisted these verification tests, lending the FDR Xair System and dispatching technicians. Due to the need to take several hundreds of X-rays per day, Fujifilm swiftly addressed the request to expand the system’s battery capacity by enabling the use of external portable power sources and solar systems.

WHO announced the new guidelines on the World TB Day on March 24, 2021, in which it recommends the use of chest X-ray as a new method of TB screening in addition to the conventional sputum tests. In August, WHO and IAEA*7 jointly unveiled recommended specifications for X-ray systems, with which the FDR Xair System complies. WHO also recommends the use of AI technology on chest X-rays to identify suspected TB cases in countries with shortages in specialists and human resources. The FDR Xair System can be connected to the compact GPU unit “Ex mobile*8”, also developed by Fujifilm, to provide compatibility with an AI-based*9 app that assists the detection of consolidations and nodules, which are main findings that lead to TB diagnosis in chest X-rays. This enables on-site analysis of diagnostic images.

Amid the COVID-19 pandemic, the FDR Xair System is used as a chest X-ray device for diagnosing pneumonia. It has been donated to countries including Cambodia as part of the Japanese government’s official development assistance (ODA) for developing countries in combating COVID-19, and Vietnam under the Grant Assistance for Grass-roots Human Security Projects.

In a bid to accelerate TB screening in regions with underdeveloped medical screening infrastructures, Fujifilm is also working with Toyota Tsusho Corporation to develop an X-ray TB screening solution, using Toyota Motor’s four-wheel-drive Land Cruiser equipped with the FDR Xair System, to accommodate communities with underdeveloped road systems and poor accessibility.

Fujifilm’s portable X-ray unit “FDR Xair”

Fujifilm’s compact and lightweight portable X-ray unit “FDR Xair” , used on patients at home or in hospital wards, weighs just 3.5kg for excellent portability and operability, supporting quick and easy X-rays and image analysis*10 even in locations with space constraints. It can be combined with the company’s Cassette DR “FDR D-EVO II” to obtain high-quality images even with low radiation dose, thereby helping to reduce patients’ radiation exposure.

Fujifilm will continue to supply various products and services that meet the needs of medical frontline to contribute to the advancement of medical care around the world, and the maintenance and promotion of human health.

  • *1 The GDF is the procurement arm of the Stop TB Partnership.
  • *2 The Stop TB Partnership is a multi-sector partnership of various partners for implementing TB measures, established in 2001 under the WHO in Geneva, Switzerland.
  • *3 The UNOPS is an international organization that specializes in project implementation. It operates assistance programs based on requests by other international organizations, international financial institutions and national governments.
  • *4 Tuberculosis, AIDS and Malaria
  • *5 “GLOBAL TUBERCULOSIS REPORT 2020” issued by the WHO
    (https://apps.who.int/iris/bitstream/handle/10665/336069/9789240013131-eng.pdf)
  • *6 The TB Reach program is aimed at delivering medical screening, treatments and other services to people in countries and regions with limited TB-related services.
  • *7 IAEA stands for the International Atomic Energy Agency.
  • *8 An optional add-on to Cassette DR to enable software installation, etc.
  • *9 Deep Learning, one of AI technologies, has been used in the design. This does not automatically affect system performance or precision after installation.
  • *10 A retaining unit, etc. is needed to take X-rays.

FDR Xair System

Portable X-ray unit “FDR Xair”
[image]
DR Cassette “FDR D-EVOII”
[image]

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FUJIFILM Holdings Corporation 
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FUJIFILM Corporation
Medical Systems Business Division