Micro-X announced today that its Rover mobile X-ray product designed for military medical facilities received FDA 510(k) clearance.
Adelaide, Australia-based Micro-X said in a news release that it initially developed the Rover product under contract from the Australian Defense Department to offer digital medical X-ray imaging technology that was light enough for deployment in field medical facilities due to weight limits for standard equipment.
Rover, which weighs in at nearly 210 lb (95 kg), offers the high power needed for trauma imaging that is normally found in conventional technology more than five times as heavy, according to the company.
Micro-X intends to commercialize Rover in the U.S. through its direct sales channel, with focus centered on the U.S., Australia, the United Kingdom and other NATO countries with the addressable market size. The company also intends to pursue CE Mark approval over the next year so it can commercialize in Europe.
“Securing FDA clearance for the Rover is a hugely exciting milestone for us as we can now start full marketing and demonstration activities of this unique product to the U.S. Army, Navy and Air Force,” Micro-X managing director Peter Rowland said in the release. “As the only deployable product with this full X-ray performance, our focus is now on ramping up sales and commercialization activities in the U.S. to convert the interest into sales.
“I would like to make a special commendation of our regulatory team who, in its first FDA submission, has secured this approval in a fraction of the normal timescale.”