FDA Clears Nanox’s Single-Source Digital X-Ray

Nano-X Imaging Ltd. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its single-source Nanox.ARC digital x-ray technology.
 
“Obtaining 510(k) clearance from the FDA for our single-source Nanox.ARC digital x-ray is a significant step forward along our US regulatory pathway,” stated Ran Poliakine, chairman and CEO of Nanox. “We remain on track to commence system shipments in the fourth quarter of 2021 and the first quarter of 2022 with the goal of finalizing deployment of the initial 15,000 Nanox.ARC systems by the end of 2024. We believe we are well positioned to achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world’s population who currently have limited or no meaningful access to imaging or the preventative screening that it offers.”
 
The Company remains on track and expects to submit a 510(k) application to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multi-source Nanox.ARC will be the company’s commercial imaging system that it expects to deploy broadly across the globe.
 
Modern X-ray equipment is said to have been digitalized. However, this change ‎has only affected the image capturing, processing, and data storage section—not ‎the actual X-ray tube itself. At the heart of every new X-ray tube, there still is a ‎metal filament that has gone virtually unchanged for the past 100 years.
 
‍The term “cold cathode” refers to a cathode that is not electrically heated by a ‎filament. While a filament boils off electrons by using heat (called a thermionic ‎emission)—a cold cathode (or a “field emitter”) extracts electrons from the metal ‎by an external electric field.‎
 
One company, Field Emission Technologies, a Sony spin-off arm, developed ‎the technical know-how to produce the world’s first high-quality FED (Field Emission Display) panel. ‎While the cold cathode ‎principle was not new to scientific researchers, the firm battled to obtain ample ‎and stable ‎electrons in a non-heat driven emission platform.‎ Nanox acquired this technology and ported it to the medical imaging field. Nanox field emission cathode technology allows X-ray imaging to overcome ‎longstanding impediments to innovation and market growth. This technology aims ‎to become a novel digital standard of X-ray imaging. Our cold cathode, made of ‎millions of nanoscale gates (called nano-spindts), digitally generates electrons and successfully replaces the thermionic filament ‎in the X-ray tube.
 
Nanox’s cold cathode can generate a specific current irrespective of the anode ‎voltage. The Nanox gate electrode practically “ejects” the electrons from the ‎cathode and controls the amount of X-ray radiation, enabling independent control of ‎the X-ray current (mA tube current) and the energy (kV) that is set at the Anode. ‎The Nanox Source technology represents the “digital ignition” for the “engine”—i.e., X-ray tube that powers the X-ray machine to start—and enables it to run ‎efficiently. With this “cool” ignition, X-ray generation is controlled with digital ‎accuracy and is free from much of the heat management requirements. ‎The X-ray “engine” becomes smart and compact.
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X-ray machines, equipped with this digital engine, will advance to a new horizon. ‎