TORONTO – Ka Imaging Inc. has received U.S. FDA 510(k) clearance for a portable, dual-energy X-ray detector that distinguishes itself from others in this class by delivering regular digital radiography, bone and tissue images in a single X-ray exposure. Designed for early detection of pneumonia, including COVID-19, the Reveal detection system also differentiates bone and soft-tissue without the physical disruptions that often occur as other parts of the body, such as the heart, move during imaging.

“We had a lot of people working from home because of the pandemic and were still able to get all the testing done for the FDA submission,” Waterloo, Ontario-based Ka Imaging president and CEO Amol Karnick told BioWorld. “FDA clearance of our technology is an amazing milestone for our company that will also make a significant contribution combatting the spread of COVID-19.”

I like this one, but love that one

When Karnick created Ka Imaging in concert with University of Waterloo electrical and computer engineering professor Karim S. Karim in 2013, their goal was the modest one of commercializing a “minimally viable” imaging product. Within short order they presented results from one of their first imaging products to a meeting of the Radiological Society of North America in December 2017.

“We got a lot of interest, but even more interest for a product other than the one we hoped to commercialize,” said Karnick. “So we decided to backburner the one we thought we’d commercialize first and bring the dual-energy X-ray detector up to the front.”

As it’s practiced today, dual energy X-ray detection is deceptively simple, producing two images, i.e., higher- and a lower-energy exposures from which radiologists attempt to distinguish a cancerous lesion or tumor, for example, from adjacent bone and tissue.

“What our dual energy X-ray imaging allows you to do is to produce in a single exposure of the lungs and ribs and look at them individually,” said Karnick. “A good example is lung cancer where you may have a lesion or tumor hiding behind the rib cage. You remove the ribcage image and now you can see the lesion.”

But another problem the Reveal system overcomes is the quarter to a half second delay that occurs when two separate exposures are produced using current dual energy X-ray imaging. The radiologist can ask you to hold your breath long enough to avoid image distortion and see the area of concern clearly. But what she can’t ask you to do is to stop the beating of your heart.

This is called this a “motion artifact” which can prompt a radiologist to misinterpret what they’re seeing as a second cancerous lesion or nodule. “We take one radiation exposure and do all this energy separation in the X-ray detector itself. That’s where the novelty lies,” said Karnick.

Faster, cheaper, portable

Just how novel should become clearer following clinical trials which have begun at Toronto’s University of Health Network. Up to six hundred participants will help determine the Reveal’s effectiveness imaging lung disease such as pneumonia. Another key function, this time useful in triaging for COVID-19 infection, will occur prior to a patient’s oxygen blood saturation level dropping.

“Right now, they’re using surrogates like pulse oxygenation to determine how well the lung is functioning,” said Karnick. “When they see they can’t help them further they put them on a ventilator.” Karnick wants to start imaging these patients earlier “to get a better idea of how their lungs are truly doing so that we can treat them earlier and better.”

In addition to earlier, more precise results, the Reveal’s single X-ray exposure will reduce radiation doses to a fraction of that currently produced. It will also be significantly cheaper, said Karnick. “Where fixed dual-energy systems can cost as high as half a million dollars, Ka Imaging’s Reveal will be less than a quarter of that price.”

The clinical trial will also examine the use of thoracic tomograms for early detection of COVID-19 in the lung. The images from both procedures will be compared with the ones obtained on a CT scan, 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.

Ka Imaging has used some of its sales revenue from other products to advance development of its portable X-ray detector, “but we’ve had private interests come in with investments as well,” said Karnick. The system is scheduled for an official launch in mid-October.