• Qure.ai will be a global distributor for MammoScreen®, Therapixel’s AI-powered decision support tool for breast cancer screening. 

• MammoScreen enables radiologists to read large numbers of screening mammograms in 2D and 3D more confidently, improving breast cancer detection accuracy and efficiency.  

Qure.ai, a leading provider of artificial intelligence (AI) software for medical imaging, today announced that its solutions were awarded the CE Class IIb certification for medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR).

Qure.ai now offers one of the most comprehensive, certified portfolios of AI-based detection devices for radiology in the EU, spanning over 31 countries. Qure’s AI helps detect abnormalities from multiple radiology modalities including Chest X-rays, Chest CT, Head CT, and Musculoskeletal X-rays. These medical devices are cutting-edge AI software that assist radiologists in interpreting radiological scans in different healthcare settings.

Concerning the newest milestone, Prashant Warier, Co-founder and CEO of Qure.ai, said, “The EU MDR certification demonstrates our commitment to meeting the highest standards of safety and effectiveness of our products. Qure's products have undergone extensive validation and have been actively deployed globally at more than 1000 sites across 75+ countries. Receiving EU MDR certification is a testament to the continued quality of our solutions, and it further strengthens our position as a trusted provider of AI software. The EU MDR certification will allow us to expand our reach in the EU market and enable better patient outcomes with our imaging AI solutions. We will continue to work closely with regulatory bodies to ensure compliance with the EU MDR and other relevant regulations". 

EU MDR certification process is rigorous and comprehensive, ensuring that medical devices meet high safety, performance, and quality standards. Qure products are validated in 71 countries.

“Last year, Erasmus MC and Qure.ai launched an AI Innovation Centre for Medical Imaging. This innovation center will evaluate Qure's solutions for their robustness and ability to improve patient outcomes. Gauging the performance of AI solutions in different population cohorts will help create evidence for their adoption in care workflows as clinical decision support tools," says Dr. Jacob J. Visser, radiologist, chief medical information officer, and assistant-professor Value-based imaging AI at Erasmus MC. “This will give detailed insights into their use cases in disease-specific workflows like lung cancer, ER, stroke, etc., and assess the added value for patient care," he added. 

The MDR certification recognizes the safety, performance, and quality of Qure.ai's AI software and confirms its compliance with EU medical device regulations. In addition, the certification assures healthcare providers and patients that Qure.ai's AI software has undergone extensive evaluation and is safe, effective, and reliable across global markets.  

Qure is thrilled to announce that qXR, Qure.ai’s Chest X-ray AI product has been successfully validated with the Fujifilm AI-enabled platform REiLI®. The integration was showcased in its full capability in a recent demo at the Radiological Society of North America (RSNA).

Partnership announcement

Qure is on a mission to use technology to enable accessible, affordable and timely care across the globe. This vision drives both our product design and growth and partnership efforts.

As a company with a focus on improving outcomes for patients, FUJIFILM Healthcare Americas Corporation (Fujifilm), is a leader in diagnostic imaging and medical informatics solutions. This makes them an ideal partner for Qure in our work to address the evolving needs of healthcare across prevention, diagnosis, and treatment. Since launching the X-ray film in 1936, Fujifilm has continually innovated to keep up with the ever-changing ecosystem and has built a global presence across their healthcare portfolio ranging from digital radiography to endoscopy, to in-vitro diagnostics and beyond.  

In the past decade, Fujifilm has committed to innovate in the AI diagnostics space, and the AI-enabled platform REiLI® is a testament to this commitment. Through the platform, Fujifilm has combined their existing image-processing technologies with AI to create an open platform that enhances the existing diagnostic imaging experience.

About the software

qXR is a CE class II certified deep learning technology that helps detect and highlight abnormalities in chest radiographs. It can detect and localize suspected abnormalities and provides results as clinically relevant tags. It can identify abnormal and normal chest X-rays and identify the presence or absence of various abnormalities.

A contemporary component of Fujifilm’s Synapse PACS, the AI-enabled REiLI® platform uses open standard APIs to support extensive integration of Qure’s algorithms to bring it directly within Synapse PACS workflow. This allows scans to be segregated and prioritized as appropriate. The results are flagged in the Synapse PACS worklist, which enables immediate reporting of critical cases without the need to get into individual case records. The AI-enabled platform, along with Synapse PACS, has the capability to store radiologist feedback of the AI results to continuously perfect Qure’s algorithm accuracy.

One example is the AI processed scans in the worklist can be triaged at a worklist level eliminating unnecessary clicks. This can be leveraged to allow workflow variations within radiology departments to reduce reporting time. The various outputs available as part of Qure’s solution ensure that we are readily available for a wide range of viewer needs globally.

Past collaborations

Fujifilm and Qure have a longstanding partnership and are expanding their scope of collaboration. qXR is also applied in Fujifilm’s modality solutions offerings which include  mobile X-ray device (FDR nano), portable X-ray devices (FDR Xair) and is in use in clinical settings to detect TB, COVID-19, lung cancer and other critical symptoms where there are a limited number of doctors.

Qure was honored to work with IHVN (Institute of Human Virology Nigeria) and Fujifilm Healthcare Middle East & Africato deploy ultra-portable x-ray machines embedded with AI in rural Nigeria to optimize TB screening outreach. In a span of 6 months, we were able to screen around 30k people with the help of 38 Fuji Xair machines along with qXR across Nigeria and helped in identifying 600+ at risk cases. 

Qure.ai has also partnered with Fujifilm as part of a TB screening workflow with clients in United Arab Emirates. The duo has established a meaningful color-coding system within Fujifilm’s Synapse Radiology Information System to support radiologists in prioritizing cases with findings from the rest of the normal cases. With the help of Fujifilm, we were able to screen around 1.5Mn people till now and going strong even further by collaborating for other care areas like musculoskeletal (qMSK) and head CT (qER)

Qure believes that collaboration is the catalyst to innovation. The next step in early diagnosis and treatment of diseases is seeing the emerging new technologies coming together. AI is key to enabling integration of imaging, clinical, and molecular data – such as liquid biopsies, to diagnose diseases even earlier. This convergence of technologies like Fujifilm’s AI-enabled platform REiLI® and Qure’s qXR has tremendous potential to help physicians prevent, intercept, and ultimately cure patients with minimal changes to workflow and enhanced AI usability experience

We look forward to expanding this partnership in other care areas and geographies reaching millions of patients meaningfully.

The new posting reiterates Qure.ai's efforts to strengthen its strategic offerings and accelerate global expansion in the public healthcare sector. 

Qure.ai, a leading health tech provider, has appointed renowned global health expert, Dr. Shibu Vijayan as its Medical Director for Global Health Practice. The company enjoys clear leadership in the global health space and the new addition of Dr Vijayan to its helm will bolster its partnerships with strategic change-makers in public health, manifold.  

Dr. Vijayan is a senior clinician in Community and Public Health Services. He has 25 years of experience in developing, monitoring, and evaluating public health projects, including developing healthcare-related proposals in both private and not-for-profit organizations. He is also an accredited International general Tuberculosis (TB) expert by the TB team hosted by WHO and Stop TB Partnership.

Prior to Qure.ai, he was at PATH and has also worked with the WHO as Technical Consultant for the TB Control Program in India and was associated with Medicines Sans Frontiers (MSF, Netherlands) as a field Epidemiologist in Ethiopia.

Commenting on the announcement, Prashant Warier, Founder and CEO, Qure.ai, said, “Dr. Vijayan comes with an enviable trove of experience, varied across the public health spectrum. He has been one of our long-standing supporters and was one of the first people to adopt qXR for TB in the Global Health community. We are delighted to welcome him as one of our own and continue our journey to improve healthcare outcomes for disadvantaged populations globally. With him at the helm of our global health portfolio, I am positive that Qure.ai will strengthen our leadership position in the application of AI solutions to deliver affordable and accessible healthcare for everyone". 

“Qure’s AI and digital solutions are targeted towards accelerating Universal Health Coverage. This dynamic team is doing stellar work towards improving global healthcare access and I am excited to be part of the journey. We will continue to strive towards optimizing global health practices and expand our footprint further to reach remote communities and their unmet medical needs”, said Dr Shibu Vijayan, Medical Director, Global Health, Qure.ai. 

Qure.ai's global health presence has been on a steady growth path. The company has increased its impact manifold during the last two years and has touched over 12 million lives across the world’s most vulnerable populations. Qure.ai's intervention during the pandemic and the continued efforts to optimize lung health screening in vulnerable communities has been a distinguisher across markets.   

The company is one of the leading AI solutions providers to be recommended by WHO, in the absence of a human reader. Qure.ai is present in 600+ sites across 60+ countries, including the UK, US, Southeast Asia, Latin America, Australia, and Africa.  

Leading health tech firm Qure.ai has partnered with Erasmus MC, University Medical Center Rotterdam, to launch the AI Innovation Lab for Medical Imaging. The initial program will run for 3 years and will conduct detailed research into the detection of abnormalities by artificial intelligence (AI) algorithms for infectious and non-infectious disease conditions. The goal will be to understand the potential use cases for AI in Europe and provide guidance to clinicians on best practices for the adoption of the technology specifically for their requirements.

Erasmus MC is recognised as a leading innovator in healthcare, pursuing excellence through research and teaching. It will run the Lab, conducting research projects using Qure’s AI technology. The initial research project will focus on musculoskeletal and chest imaging.

“We are delighted to be partnering with Qure.ai, as we see the adoption of AI in healthcare at a critical juncture, where clinicians are asking for expert advice on how best to evaluate the adoption of the technology. In Qure's work to date, it is clear they have gathered detailed insights into the effectiveness of AI in healthcare settings, and together we will be able to assess effective use cases in European clinical environments" said Dr. Jacob J. Visser, Radiologist, Chief Medical Information Officer, and Assistant-Professor, Value-based Imaging, at Erasmus MC. 

Healthcare systems across Europe have faced financial pressures due to the pandemic. Resources are constrained as it is a challenge to recruit specialist consultants and radiologists. Adopting AI can alleviate clinicians' burden and provide adequate early warning systems and ongoing monitoring of abnormalities. Qure is already seeing benefits of automated detection of anomalies and progressive detection where AI can provide a more accurate and efficient analysis of tumours.

“Our work to date worldwide has shown many examples of where AI can prove invaluable to clinicians and patients. Our work with Erasmus MC is a critical part of our commitment to provide European clinicians with the validation and best practice they need to give them the confidence to adopt AI. Furthermore, given their global reputation in research for medical imaging and diagnostics, we look forward to producing robust and insightful analysis on the role of AI in European healthcare settings with the team at the AI Innovation Lab for Medical Imaging" said Prashant Warier, CEO and Founder, Qure.ai.

Over 3 years of the partnership, multiple radiologists and PhD students will work in the AI innovation centre to generate evidence and publish them in peer-reviewed journals. The team will focus on AI for Chest CTs, X-rays and brain CTs.

Qure's technology is used in over 500 healthcare facilities in 50 countries. It has successfully run ground-breaking initiatives in remote medical diagnostics, such as its mobile medical van programme for Tuberculosis(TB) in Africa, India and Southeast Asia. It is working with Astra Zeneca to integrate innovative artificial intelligence (AI) solutions for the early detection of lung cancer. In addition, Qure has always invested in strong collaborations with premier academic institutes globally, which have helped independent validations of the performance of their algorithms.

• Fujifilm’s Xair ultra-portable handheld, battery powered X-ray machine will be deployed with Qure.ai’s AI-enabled Chest X-ray solution to screen presumptive TB cases
• The partnership is aimed at augmenting active screening for TB in hotspots with the support of USAID and the Lagos State TB program.

The Institute of Human Virology in Nigeria (IHVN) has announced their partnership with Fujifilm, the multinational medical imaging device manufacturers and Qure.ai, a global AI-enabled medical imaging solutions provider to use advanced technology to help optimize tuberculosis (TB) screening outreach in Nigeria. The partnership has enabled USAID funded IHVN to deploy ultra-portable X-ray machines embedded with AI for active case finding in Nigerian rural communities.

TB is the leading cause of death in Sub-Saharan Africa (Nigeria inclusive) and the most common opportunistic co-infection alongside HIV. Fujifilm’s Xair portable Xray device powered by the Qure.ai’s artificial intelligence algorithm provides an ideal solution for rural mass testing programs, offering ultra-portability, high accuracy, and efficiency point-of-care diagnostic solutions. 

Dr. Chukwuma Anyaike, Director and National Coordinator, National Tuberculosis, Leprosy and Buruli Ulcer Control Program – Federal Ministry of Health NIGERIA, said; “The successful piloting of the use of portable digital x-ray from Fujifilm with Qure Ai technology by IHVN in collaboration with NTBLCP, Federal Ministry of Health Nigeria has proven its positive impact on case detection of tuberculosis."

Commenting on the partnership, Dr Aderonke Agbaje, Chief of Party USAID TB-LON 3 Project at Institute of Human Virology Nigeria said: “IHVN is at the forefront of battling TB and correlated infections using innovative solutions to optimise care delivery. Through our efforts (rural dwellers in communities with difficult terrains have been reached with TB care). Our partnership with Fujifilm and Qure.ai for AI enabled TB screening is our most recent initiatives towards community outreach. We look forward to scaling active case finding efforts and improving patient care."

The United States Agency for International Development (USAID) is working with IHVN to rapidly increase the level of TB cases detected and treated in Nigeria over the next five years. The project aims to improve access to high-quality, patient-centric treatment for TB, including drug-resistant tuberculosis and co-infections with HIV, which is common in the community. The project also covers contact tracing of TB presumptive cases to curb contagion and bring more cases under the aegis of the national TB reporting system. IHVN is the implementing partner for the project that covers the states of Lagos, Osun, Ogun, and Oyo.  

Commenting on the development, Godspower Asika, National Sales Manager – Nigeria, Fujifilm Middle East & Africa, said “We are happy to note that IHVN is screening numerous communities in Nigeria with our ultra-portable x-ray machine, the Fujifilm FDR Xair, which is integrated with AI technology from Qure Ai. We applaud the Federal Ministry of Health of Nigeria's NTBLCP leadership for working kindly with IHVN to accomplish this, and Fujifilm will continue to make its technology available to all partners and stakeholders.”

Fujifilm FDR Xair is a battery-powered, ultralight, and compact X-ray device that can function for hours without electricity. FDR Xair, coupled with Qure.ai’s Al-powered radiological image analysis allows for accurate screening & detection of lung abnormalities, and presumptive TB even in the remotest parts of the world and can be beneficial in expediting the process of TB diagnosis at the point of care.

Commenting on the partnership, Prashant Warier, CEO and Founder, Qure.ai said; “We are excited to partner with Fujifilm on this project to combine two state-of-the-art technologies for the greater communal good. Our AI enabled chest X-ray solution, qXR, has been evaluated by WHO and meets their criteria for TB triage and screening in the absence of a human reader. IHVN’s Nigeria project will help reinforce what superior technology can do for universal lung health and healthcare access for everyone.”

Qure.ai's chest X-ray software can detect multiple lung abnormalities within a minute. It can accurately assess radiological findings suggestive of a host of diseases, including pneumonia, COPD, TB, and Heart Failure, among others.

Together IHVN, Fujifilm and Qure aim to strengthen the systems and structures for tuberculosis detection,treatment, and notification in rural Nigeria. The partnership will help in reducing the transmission and progression of tuberculosis and aid in accelerating tuberculosis research and innovation to improve the quality of programs implemented.