A Canadian Medical Device Licence was issued Sept. 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, Chief Technology Officer 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.
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