Met de certificering kan het bedrijf de detector in meer dan 30 nieuwe landen commercialiseren

WATERLOO, Ontario–(BUSINESS WIRE)– De innovatieve Reveal™ 35C flatpanel-detector van KA Imaging heeft het EU MDR CE-markeringscertificaat ontvangen van de aangemelde instantie van de EU. De röntgendetector, aangedreven door gepatenteerde SpectralDR™-technologie, is nu gekwalificeerd voor verkoop in elk van de 27 landen van de Europese Unie, plus de vier landen die deel uitmaken van de European Free Trade Association (EFTA).

“Het is een heel spannend moment voor ons bij KA Imaging”, zegt Amol Karnick, President en CEO van KA Imaging. “We zijn in gesprek met veel klinische locaties in Europa, en de CE-markering stelt ons in staat installaties te maken en patiënt beeldvorming te starten”, zei Karnick.

KA Imaging’s Reveal 35C Receives CE Mark Certificate

With the certification, the company can commercialize the detector in more than 30 new countries

WATERLOO, Ontario–(BUSINESS WIRE)– KA Imaging’s innovative Reveal™ 35C flat panel detector has received EU MDR CE Mark Certificate from the EU Notified Body. The X-ray detector, powered by patented SpectralDR™ technology, is now qualified for sale in any of the 27 countries of the European Union, plus the four countries that are part of the European Free Trade Association (EFTA).

“It’s a very exciting moment for us at KA Imaging,” said Amol Karnick, President and CEO of KA Imaging. “We are engaged in conversations with many clinical sites in Europe, and the CE Mark will allow us to make installations and start patient imaging,” said Karnick.

KA Imaging’s SpectralDR™ technology enables dual-energy subtraction, providing bone and tissue differentiation with a single standard X-ray exposure. It acquires three images simultaneously (DR, bone and soft tissue dual-energy X-ray images). The technology mimics the workflow, dose and techniques of state-of-the-art mobile DR X-ray detectors.

“Thanks to SpectralDR™, the Reveal 35C takes general X-ray to the next level because you can simultaneously get true bone and soft tissue subtracted images for any X-ray clinical task plus a high-quality DR image in one exposure at the lowest dose,” said Dr. Karim S. Karim, CTO at KA Imaging.

The spectral images provide enhanced visualization of abnormalities including indeterminate lung nodules, coronary calcium, pneumonia, tips of lines and tubes, pneumothorax, in-dwelling devices and retained surgical bodies.

About KA Imaging

A spin-off from the University of Waterloo, KA Imaging specializes in developing innovative X-ray imaging technologies and systems, providing solutions to the medical, veterinary, and non-destructive test industrial markets. For more information, visit www.kaimaging.com.

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Fernanda Fraga

Media Relations

ffraga@kaimaging.com
T: 226.215.9897