Canadian manufacturer is getting ready to launch Reveal™, the only portable dual-energy X-ray detector on the market
WATERLOO, Ontario–(BUSINESS WIRE)- For the first time, practitioners will be able to leverage dual-energy X-ray technology in a portable system. Canadian manufacturer KA Imaging is getting ready to launch Reveal, the world’s first dual-energy X-ray detector that can be taken to the bedside. “Due to infectious nature of COVID-19, bringing patients into a fixed radiology room can sometimes be risky,” explains Amol Karnick, President and CEO of KA Imaging. “Current dual-energy systems are all fixed and Reveal overcomes the limitation of a fixed room by providing a world first portable dual energy solution. Reveal provides radiologists with an unobstructed view of the lungs by removing the bones in an X-ray image,” he continues.
The FDA 510(k) pending detector works with a single exposure. Unlike fixed dual energy solutions, Reveal’s technology enables bone and soft tissue differentiation with no motion artifact. “Our patented technology also allows lateral and oblique dual energy views for the first time,” explains Dr. Karim S Karim, CTO at KA Imaging.
Whereas fixed dual-energy systems can cost as high as half a million dollars, KA Imaging’s Reveal is highly affordable at less than ¼ of this price.
“If a hospital requires dual energy X-ray for COVID-19, you can simply replace any older CR plate or digital fixed or portable detector with Reveal,” says Karnick.
The company is planning clinical trials globally to demonstrate the efficacy of Reveal in triaging COVID-19 and other imaging tasks in the Emergency Room and Intensive Care Units. One of them is expected to begin in Toronto by August. “The world needs affordable and effective portable bedside diagnostics now, and Reveal is a solution that can provide tremendous value for clinicians, hospitals and government,” emphasizes Karim.
Reveal is also being tested on patients with lung cancer. Grand River Hospital (Kitchener, Ontario, Canada) was the first to test the technology. More than 20 patients have been imaged with Reveal, with promising initial results.
Radiologists globally can learn more about Reveal at the European Congress of Radiology (ECR) from July 15th to 19th. Due to the pandemic, the conference will be held online. KA Imaging is part of the virtual exhibition.
Deutsches Elektronen-Synchrotron (DESY), a Research Centre of the Helmholz-Association, is promoting virtual Workshops on Powder Diffraction and Biological & Medical Imaging. The events will be between June 22 – June 25.
KA Imaging is part of both programmes:
X-ray Powder Diffraction at DESY Talk 7: Micron Scale Pixel Hybrid Detector for Hard X-rays Speaker: Prof. Dr. Karim S. Karim, CTO of KA Imaging Time:03:05 PM – 03:25 PM – Europe/Berlin timezone – 9:05 AM – 09:25 AM Eastern Time Register now: https://indico.desy.de/indico/event/26187/
Biomedical Imaging at PETRA III and PETRA IV
Talk:8 micron pixel pitch direct conversion X-ray detector for phase contrast X-ray imaging in biomedical applications Speaker: Chris Scott, engineer at KA Imaging Time: 02:10 PM – 02:30 PM – Europe/Berlin timezone – 08:10 AM – 08:30 AM Eastern Time Register now: https://indico.desy.de/indico/event/25334/
About the workshops:
X-ray Powder Diffraction at DESY In order to identify current and future scientific and industrial demands in X-ray powder diffraction applications a virtual workshop will be held on June 22th – 25th 2020. This workshop will gather the input from the user community on how to evolve and enhance the methods and techniques provided within the existing PETRA III diffraction stations as well as beyond. The workshop is meant to serve as a melting pot for new ideas from science and industry. The aim is to identify key aspects and provide DESY with a community backed concept for current and future developments (e.g. development of new beamlines at PETRA III / PETRA IV).
Biomedical Imaging at PETRA III and PETRA IV The scope of the workshop is to bring together current and future users of Biomedical Imaging facilities to exchange ideas and trends as well as identify beamline parameters which could help enable the envisaged imaging projects at PETRA III and PETRA IV. This will also help in gathering information on the evolution and enhancement of methods and techniques provided at the existing PETRA III imaging stations as well as for envisaged stations at PETRA III and PETRA IV. The workshop is expected to cover a broad range of applications from molecular crystallography to possible in vivo studies on animals.
UPDATE April 04 2020: The office is still closed. Work and meetings will continue online until further notice.
Office will be closed until the end of March; period can be extended
In response to the emergence in Ontario of COVID-19, all KA Imaging employees are working from home for the next two weeks starting today. Work and scheduled meetings will continue online.
The Waterloo-based company has around 30 employees, 20 of whom work directly in the office. “The outbreak is growing. We need to be cautious and ensure we take the necessary steps to protect the health of our team and our community,” says Amol Karnick, president and CEO of KA Imaging. “We are doing our part to curb and contain the spread of COVID-19 so that we can all go back to normal daily lives faster,” he continues.
The initial two-week period of home-office will be revised and may be extended, depending on how the pandemic evolves in Canada.
As the number of infections gets higher, experts from different fields are trying to find ways to help stop the disease from spreading
The latest situation report from WHO points to more than 105,000 confirmed cases globally. As the number of infections gets higher, experts from different fields are trying to find ways to help stop the disease from spreading. In this interview, KA Imaging’s CTO, Karim S. Karim, discusses how Reveal’s technology could strengthen efforts against the spread of the novel Coronavirus. Reveal is undergoing IEC testing and will be submitted to the FDA for US 510K regulatory clearance in 2020.
How can Reveal’s technology help diagnose of COVID-19?
Karim: Dual-energy subtraction radiography is widely known for classifying lung nodules for diseases like lung cancer, pneumonia and tuberculosis. Initial studies have demonstrated the improvement of the area-under-the-curve for detecting pneumonia from 0.84 to 0.88 by using the technique1. Thus, the use of dual-energy X-ray in COVID-19 to detect manifestations of the disease in the lungs may contribute to improve diagnosis – especially because Reveal is the only available option that is motion artifact free.
What does “motion artifact free” mean?
Karim: Current dual-energy X-ray implementations are not mainstream because they require acquisition of two X-ray exposures at different energy levels. This double-exposure leads to blurring artifacts due to heart-beating or breathing motion, producing streaks. These artifacts often invalidate the resulting images and force retakes, which is time – and money – consuming. This problem doesn’t happen with Reveal. Our detector uses a patented three-layer sandwich design to acquire images simultaneously from only one exposure. Post-acquisition imaging processing allows the creation of high-quality traditional DR, bone subtracted, and tissue subtracted images. Price also acts like a barrier. A full new dual-energy system can cost as much as half a million dollars, and not many institutions have the resources to invest in this type of high-end technology. Reveal, on the other hand, was designed to be retrofittable. It means that, for a quarter of that price, we can upgrade an existing conventional X-ray system. The install base of all conventional X-ray systems is around 500,000 globally.
Why is early diagnosis so important?
Karim: The World Health Organization says that “earlyepidemiologic and clinical investigations are critical to carry out early in an outbreak of a new virus”. False negative tests can play an important role in spreading COVID-19, as the patient remains untreated and in contact with others. When the virus is novel, as COVID-19, the challenges are even greater. Recent experiences have shown that testing for viral RNA may not suffice as the only test to confirm or rule out the infection. . This is where we can help, as radiological imaging, in some cases, has indicated presence of pulmonary disease even days earlier than PCR testing2. Moreover, radiological imaging can follow the progress of COVID induced pneumonia over time enabling timely decision making about treatment efficacy or need for ventilators.
What about CT?
Karim: CT is the current clinical reference standard in the detection of pulmonary manifestations of infectious diseases. Though effective, this method suffers from low availability and still exposes patients to high doses of radiation. Even moving the patient to the CT location can represent an extra risk of spreading the virus. The method is undeniably essential but developing alternatives that can increase access and safety is urgent.
What are your next steps?
Karim: A clinical trial comparing conventional X-ray, dual energy X-ray, and computed tomography (CT) is necessary to quantitatively establish the relative performance of all three radiological methods of detecting COVID-19. KA Imaging is actively seeking clinical and government partners to obtain the necessary clinical evidence to determine deployment conditions and to accelerate adoption.
Li F, Engelmann R, Pesce L, Armato SG 3rd, Macmahon H. Improved detection of focal pneumonia by chest radiography with bone suppression imaging. Eur Radiol. 2012 Dec;22(12):2729-35. doi: 10.1007/s00330-012-2550-y. Epub 2012 Jul 5
Wong, H. Y. F., Lam, H. Y. S., Fong, A. H.-T., Leung, S. T., Chin, T. W.-Y., Lo, C. S. Y., … Ng, M.-Y. (2020, March 27). Frequency and Distribution of Chest Radiographic Findings in COVID-19 Positive Patients. Retrieved from https://pubs.rsna.org/doi/10.1148/radiol.2020201160
At KA Imaging, we are committed to the design and development of X-ray systems that meet the needs of our customers. Through the implementation of our quality processes, we will comply with all applicable regulatory requirements and maintain the effectiveness of the Quality Management System. We build quality in all we do.
Therefore, at KA Imaging, quality is everybody’s business! It is a journey of continuous improvement. The question is: how do you achieve quality?
Quality is defined as Conformance to Requirements. That is, any product, service, or process that conforms to its requirements is a Quality Product, Service, or Process.
At KA Imaging, ‘Quality’ is based upon Process Management and Improvement Methodology (PM&I). It focuses upon processes and their efficiencies that produce their outcomes in a consistent and a repeatable manner. The process outcomes must meet their agreed upon requirements. The pictorial view below represents KA Imaging’s PM&I model.
For KA Imaging to function effectively, it has identified and has linked all business processes. The application of a system of processes within an organization, together with the identification and interactions of these processes and their management to produce the desired outcome, can be referred to as the “process approach”. The linking of the processes to produce outcomes is also known as inter-related processes.
KA Imaging deploys a RASUI concept in its approach towards designing and developing products. RASUI is an acronym that stands for ‘Reliability, Availability, Serviceability, Usability, and Installability’.
KA Imaging being in the business of Development and Manufacturing of medical devices such as high-end Dual-Energy X-Ray Detectors, it is crucial that it consistently meets the ISO 13485:2016 Standard and Regulatory requirements. To this end, KA Imaging engages in training all its employees in the Process based Quality Management System including Management.
Amol is a seasoned executive in the medical device industry. His experience covers the whole spectrum; from start-ups (Ultrasonix, Sentinelle Medical, Ventripoint) to large OEMs (GE Healthcare). Entering into the profession with a Bachelors in Engineering from UW and a Masters in Electrical Engineering from McGill, Amol spent 20 years in the medical imaging space to become a leader of multidisciplinary teams (sales, engineering and operations). Amol is now poised to steer KA Imaging into a position of global leadership.
A professor of Electrical and Computer Engineering at the University of Waterloo, Dr.Karim is a distinguished academician known for pioneering and commercializing large area current mode active pixel sensor technology that is now used in bio-metric fingerprint readers for mobile phones. With 20 years of experience in designing and prototyping large area digital imagers, Dr.Karim has been instrumental in raising over $12 million in research funding. A full member of the American Association of Physicists in Medicine (AAPM), Dr.Karim is also an IEEE distinguished lecturer.
Sina is the co-founder and the lead of the design team at KA Imaging Inc. He brings over 7 years of experience in design and characterization of imaging detectors to the KA Imaging Inc. He has designed the state of the art imaging detector prototype and currently leading the design team at both device and system level. Sina holds a Masters in Science degree in Electrical Engineering from the University of Waterloo and is also working towards his PhD at University of Waterloo.
Joan Medley, Quality Regulatory Expert (ISO 13485)
Joan began her career as a Medical Radiation Technologist at Sunnybrook Health Sciences, specializing in general and trauma radiography, CT scanning, angiography, heart catheterizations and fulfilled the role of clinical instructor. She has co-authored a Quality & Regulatory college course providing outline, course content and learning objectives. With over 2 decades of experience as a Quality Assurance (QA) Manager and Director, Joan has led medical device manufacturers through ISO registration and managing Quality Management systems. Certified as an ISO 13485 Lead Auditor, Joan currently provides contract services for a certification body.
Jill Zappitelli, Human Resources Consultant (CHRL)
An experienced and accredited Human Resource Professional and Program/Project Manager, Jill’s rich expertise and national and international experience in every facet of Human Resources affords her the distinction of being one of the most sought-after HR professionals in the region. As a member of the HRPA Board of Directors, her CHRL designation combined with a Business Administration Management Diploma from Conestoga College – Jill brings a genuine level of confidence to any organization that finds itself without some HR guidance.
Creating and implementing authentic and effective HR solutions to solve an array of employee challenges have been Jill’s signature for several years with companies ranging from SunLife Financial to Blackberry, to non-profits such as Trellis Mental Health. Now, as a consultant to Waterloo’s emerging businesses and tech community, Jill has been delivering relevant and meaningful solutions to scale – be it program level or simply getting the right advice.
Ako Williams is Vice President, General Counsel and Corporate Secretary of Ushio America, Inc., which is a U.S. subsidiary of Ushio Inc. in Tokyo, Japan. Ushio is a leading provider of light sources and solutions for a wide variety of applications, including medical imaging and illumination, scientific, semiconductor, entertainment, horticulture, and architectural applications. A seasoned global enterprise executive with a strategic problem solving approach, Ako oversees Ushio America’s legal, regulatory compliance, risk management, and corporate governance matters. Previously, she was an Assistant General Counsel and Compliance Officer of Christie Digital Systems USA, Inc. (an Ushio group company) and an Assistant General Counsel of a leading home healthcare provider in the U.S. She holds a B.S. (highest distinction) from Northwestern University and a J.D. from Loyola University Chicago School of Law.
Dr. Ian Cunningham is a professor and scientist at the Robarts Research Institute at The University of Western Ontario and physicist at London Health Sciences Centre. He directs a research team of graduate students and post-doctoral fellows that are investigating new ways of acquiring and displaying medical images using digital radiography and computed tomography for improved health care.
Working for the World Bank got Susan interested in health and economics. Dr. Horton then proceeded to work at the International Centre for Diarrheal Disease Research in Bangladesh while writing her thesis. She has worked or taught in about 25 low and middle income countries, on topics ranging from labour markets, women's participation, benefits and costs of micronutrient interventions, and currently costs and benefits of breastfeeding, cost and cost-effectiveness of cancer interventions, and disease control priorities in low and middle income countries. Currently, Dr.Horton is working on the Disease Control Priorities project and in the past, worked on research projects with the World Bank, FAO, WHO, UNICEF, Copenhagen Consensus, etc.
Ruben has a strong background in finance, accounting and strategic business operations from several years of work experience in various industries. Prior to joining KA Imaging's team, Ruben gained valuable experience working for Canadian and Global firms such as Class 1 Inc. and Bimbo Bakeries. Ruben has been a Chartered Professional Accountant and Certified Management Accountant for over ten years.
David Bell is a clinical and public health physician with a PhD in population health and background in internal medicine, modelling and epidemiology of infectious disease. Previously, he was Director of the Global Health Technologies at Intellectual Ventures Global Good Fund in the USA, Programme Head for Malaria and Acute Febrile Disease at FIND in Geneva, and coordinating malaria diagnostics introduction and scale-up with the World Health Organization in Manila and Geneva. David specializes in point of care technology development and introduction in low-resource health systems.
Evan Lee is a Geneva-based global health consultant. He has a BA from Harvard, an MD from New York University, and an MBA from MIT. He has worked with Médecins Sans Frontières in Kenya and Uganda and for Foundation for Innovative New Diagnostics and Management Sciences for Health. Most recently, he led Eli Lilly’s global health programs working on MDR-TB and NCDs, and founded Lilly’s 30x30 initiative to reach 30 million people by 2030.
David Koff (MD FRCPC) is a Professor of Radiology at McMaster University, former Chair and Chief of the department. He is founder and director of MIIRCAM, the Medical Imaging Informatics Research Centre at McMaster, and Chair and co-founder of Canada Safe Imaging.
He has been a co-founder of IHE Canada (Integrating the Healthcare Enterprise) and is a member of the IHE section of the Medical Informatics Committee and RSNA. He is also a past co-Chair of the IHE International Radiology Planning Committee. Dr. Koff is fellowship trained in chest and body imaging.
Experienced regulatory affairs and quality assurance professional with a demonstrated history of developing and executing strategic regulatory submissions across global markets as well as implementing and maintaining quality management systems focusing on Health Canada, US FDA, MDR, MDSAP and ISO compliance.
Bob brings 20+ years of management experience in the medical device industry to KA Imaging. Prior to joining KAI, Bob held various executive commercial roles with GE Healthcare in the areas of ultrasound and mammography, where most recently was the GM of Enterprise Sales. Prior to that Bob held various general management positions in Cardiovascular Ultrasound. Bob’s commercial experience at GE ranges from building and integrating startup business to rebuilding existing commercial teams. While at GE, Bob developed indirect and direct distribution models to serve customers across all market segments. Bob received his BS and MS degrees in Management from Lesley University.