KA Imaging’s Portable Dual-energy X-ray Receives Canadian Medical Device Licence from Health Canada

Canadian market comprises more than 1,000 hospitals. The number of medical and diagnostic laboratories (which include X-ray) surpasses 3,000.  

Waterloo, Ontario – A Canadian Medical Device Licence was issued September 24 by Health Canada for Reveal 35C™, created by KA Imaging – a University of Waterloo spin-off company.

Reveal is a portable dual-energy X-ray detector that enables bone and soft-tissue differentiation without motion artifacts in a single X-ray exposure. The detector simultaneously delivers DR, bone, and tissue images in one shot. Reveal can be taken to the bedside of vulnerable patients in hospital and used easily to aid emergency procedures. It is also affordable and comes at a quarter of the price of many fixed dual-energy systems.

“Getting this Health Canada licence is a major step forward for KA Imaging, especially coupled with the recent FDA clearance. As a Canadian company we are thrilled to have received Health Canada’s approval and eagerly anticipate providing our solution to the Canadian market for advance in the field of X-ray ,” said Amol Karnick, President and CEO of KA Imaging.

Statistics from the Industry Canada database from 2019 show that there are more than 1,000 hospitals (including general and specialized facilities) in the country, and more than 3,000 medical and diagnostic laboratories – including X-ray services. In addition, because the detector is portable – it is the only portable dual-energy solution on the market – less obvious sectors can also benefit from the technology.

“At long-term care facilities, which care for vulnerable populations that can suffer from mobility limitations or health concerns, taking the detector to the patient can be very beneficial,” said Dr. Karim S. Karim, CTO of KA Imaging.

Reveal is already being used in clinical trials with promising results. The detector is being tested on patients suspected of having lung cancer at Grand River Hospital in Kitchener, and for detection of pneumonia (including COVID-19) in a Toronto-based hospital. 

“Early triaging is an essential countermeasure to prevent the spread of COVID-19 infection, and we are confident that our technology can make a significant contribution,” said Karim.

About KA Imaging

A spin-off from the University of Waterloo, KA Imaging is a Canadian company that specializes in developing innovative X-ray imaging technologies and systems, providing solutions to the medical, veterinary and NDT markets. The company has successfully developed a line of innovative X-ray imaging products in the areas of phase contrast micro-computed tomography, ultra-high spatial resolution X-ray detectors and large area digital, dual-energy X-ray material separation detectors.

Contacts

Fernanda Fraga
ffraga@kaimaging.com
226 215 9897

 

Learn more about Reveal.

Contact us and send your inquiry today.

Read more

Dual-Energy X-Ray And Thoracic Tomograms Are Tested In Canadian Trial On Covid-19 Pneumonia

600 patients are expected to be recruited in the next six months. Study also includes development of an artificial intelligence model

WATERLOO, Ontario– Two novel technologies developed in Canada have begun testing this week at the Toronto-based Princess Margaret Cancer Centre  at University Health Network (UHN)). KA Imaging, a University of Waterloo spin-off company, has partnered with a team of researchers from the University of Toronto and UHN in a study for the early detection of COVID-19.

“We want to develop and evaluate two novel imaging techniques, specifically dual-energy X-ray and thoracic tomograms, for early and reliable detection of COVID-19 manifestation in the lung,” explained Dr. Patrik Rogalla, principal investigator of the study.

The images from both procedures will be compared with the ones obtained on a CT scan, which is currently the standard of care for confirming pneumonia. The data will allow researchers to build an artificial intelligence model for automated and nearly instant image interpretation.

“Early triaging is an essential countermeasure to prevent the spread of COVID-19 and we are confident that our technology can make a significant contribution,” said Dr. Karim S. Karim, CTO of KA Imaging.

KA Imaging’s RevealTM, a patented portable dual-energy X-ray solution, will be one of the two novel modalities to be evaluated.

“Dual-energy X-ray isn’t new, but what we did with Reveal cannot be accomplished by anyone else in the world,” explained Karim.

With one shot, Reveal produces three images: one that is a regular digital radiography, another that highlights just the bones, and a third one that removes the bones to show only the soft tissue.

“All three images are sharp and free of motion artifacts, which are like streaks or defects that are frequently seen in other dual-energy technologies.  Also, unlike other dual energy solutions or CT machines, Reveal is portable so it can be taken to the patient, minimizing the risk of spread of COVID-19 infection,” commented Dr. Karim.

The other technology to be tested, Thoracic Tomogram (TT), has been developed by Dr. Rogalla’s research group. It is a novel image post-processing technique that simplifies interpretation. The technique will be applied to exploit the complementariness between CT scans and X-ray images.

“What we propose is an innovative, multimodal, deeplearning architecture for COVID-19, with a promise to gain higher accuracy of diagnosing COVID-19 than methods based on one single image type,” said Dr. Rogalla.

The goal is to recruit 600 people with suspected pulmonary infection to participate in the study over the next six months.

About KA Imaging

A spin-off from the University of Waterloo, KA Imaging is a Canadian company that specializes in developing innovative X-ray imaging technologies and systems, providing solutions to the medical, veterinary and NDT markets. The company has successfully developed a line of innovative X-ray imaging products in the areas of phase contrast micro-computed tomography, ultra-high spatial resolution X-ray detectors and large area digital, dual-energy X-ray material separation detectors.

 

Learn more about Reveal™

Send your inquiry today

Read more

FDA Clears KA Imaging’s Portable Dual-energy X-Ray Detector

With the 510(k) clearance, practitioners can leverage dual-energy at the bedside for the first time

WATERLOO, Ontario– KA Imaging’s portable dual-energy X-ray detector have received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Reveal™ enables bone and soft-tissue differentiation without motion artifacts in a single X-ray exposure. In other words, with one shot, the detector simultaneously delivers DR, bone, and tissue images.

“We are excited to announce the clearance of Reveal™, after years of dedicated work, and we will strive to apply this technology directly to help patients and medical personnel through these trying times,” said Amol Karnick, President and CEO of KA Imaging.

The different applications for this technology include providing radiologists with unobstructed views of the lungs, which can aid in the visualization of pneumonia, fractures, catheters, and masses with high sensitivity. “The soft tissue and bone images are sharp and free of motion artifacts which increases the diagnostic sensitivity,” said Dr. Karim S. Karim, CTO of KA Imaging.

Reveal is also portable, and can be taken to the bedside of patients, which is critical during these pandemic times.

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.

“Any hospital can now benefit immediately from higher sensitivity X-ray imaging by simply adding dual energy capability to any installed fixed or portable X-ray machines,” said Karnick.

Clinical trials

A new clinical trial began this week in Toronto to seek early and reliable detection of pneumonia (including COVID-19).

“Early triaging is an essential countermeasure to prevent the spread of COVID-19 infection, and we are confident that our technology can make a significant contribution,” said Karim.

Reveal is also being tested on patients with lung cancer at Grand River Hospital in Kitchener, with promising results.

About KA Imaging

A spin-off from the University of Waterloo, KA Imaging is a Canadian company that specializes in developing innovative X-ray imaging technologies and systems, providing solutions to the medical, veterinary and NDT markets. The company has successfully developed a line of innovative x-ray imaging products in the areas of phase contrast micro-computed tomography, ultra-high spatial resolution X-ray detectors and large area digital, dual-energy X-ray material separation detectors.

Reveal detector

www.kaimaging.com

Read more

KA Imaging’s X-ray Detector Allows Dual Energy to be Taken to the Bedside

Canadian manufacturer is getting ready to launch Reveal™, the only portable dual-energy X-ray detector on the market

 

Photo of the Reveal detector
Reveal™ flat panel detector

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.

Clinical trials

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.

ECR

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.

Contacts

Fernanda Fraga
ffraga@kaimaging.com
226 215 9897

Read more

KA Imaging’s X-ray Detector Allows Any X-ray System to Be Upgraded to Dual-Energy

Canadian manufacturer is getting ready to launch Reveal™, enabling bone and tissue differentiation without motion artifacts

Reveal™ Dual-Energy X-ray Detector

Canadian manufacturer KA Imaging is preparing to launch Reveal, a premium X-ray detector that upgrades any X-ray system to dual-energy. “Reveal is the ideal retrofit solution as it will fit into any ISO standard size tray,” explains Amol Karnick, president and CEO of KA Imaging. Thanks to this feature, the cost of implementation can be reduced to a fraction of the price: whereas conventional dual exposure dual-energy systems can cost as high as half a million dollars, KA Imaging’s Reveal can be obtained at a quarter of this price. “You can simply replace your old detector with Reveal, as it will work with any conventional portable or fixed X-ray source,” continues Karnick.

The competitive pricing strategy is just one of the advantages. KAI developed a unique technology that can improve dual-energy X-ray images. Reveal is the world’s first portable digital detector capable of separating different energy levels with a single exposure. It delivers three images: traditional DR, soft tissue and bone. “Our patented technology eliminates the motion artifact problem often seen in traditional dual exposure dual-energy X-Ray imaging systems,” explains Dr. Karim S Karim, CTO at KA Imaging. According to Karim, the detector simultaneously enables DR images with very high DQE (detective quantum efficiency) allowing for low radiation exposures to the patient and excellent quality soft tissue and bone images.

The Reveal detector has been used clinically on more than 20 patients with lung cancer. The clinical trial is being held at Grand River Hospital in Kitchener, Ontario and is expected to scan up to 30 patients.

Reveal is being submitted to the US FDA for clearance in 2020. Radiologists globally can learn more about Reveal at the European Congress of Radiology (ECR) between March 11th to 15th at the Austria Center Vienna. KA Imaging is exhibiting at booth #G41.

ECR is one of the largest medical meetings in Europe. Canada is a featured country at this event. “We are proud that as a partner country, we are able to present Canadian technology at this year’s ECR,” says Stéphane Charbonneau, Consul and Senior Trade Commissioner at the Embassy of Canada in Vienna.

Read more
Amol Karnick, CEO (M.Eng, BASc)
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.
Do you want more traffic?
Dignissim enim porta aliquam nisi pellentesque. Pulvinar rhoncus magnis turpis sit odio pid pulvinar mattis integer aliquam!
  • Goblinus globalus fantumo tubus dia montes
  • Scelerisque cursus dignissim lopatico vutario
  • Montes vutario lacus quis preambul den lacus
  • Leftomato denitro oculus softam lorum quis
  • Spiratio dodenus christmas gulleria tix digit
  • Dualo fitemus lacus quis preambul pat turtulis
  • Scelerisque cursus dignissim lopatico vutario
  • Montes vutario lacus quis preambul den lacus
SUBSCRIBE TO OUR NEWSLETTER AND START INCREASING YOUR PROFITS NOW!
* we never share your e-mail with third parties.
Karim S. Karim, CTO
(PhD, PEng, MBA)
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 Ghanbarzadeh, Co-Founder
(MSc, PhD*)
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 S. Williams, Vice President
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.
(B.S, J.D)
Ian Cunningham (BSc, MSc, PhD)
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.
Susan Horton (BA, MA, PhD)
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 Romero (CPA, CMA)
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 (PhD)
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 (BA, MD, MBA)
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)
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.
Sandy Pironaggi-Trocchi (BSc)
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.
Robert Moccia (BS, MS)
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.