FDA clearance opens market for Micro-X’s Rovers.
Micro-X’s Rover mobile x-ray machine has been given unfettered access by regulators to the US healthcare’s US$170 million mobile x-ray market.
A decision by the Food and Drug Administration (FDA), clearing Micro-X’s application to the FDA for its Rover mobile x-ray machine complements last year’s clearance of the machine for military use.
It opens a pathway for sales to virtually all hospitals and radiography clinics as we develop multiple paths to market for our Rover mobile x-ray machine.
The latest FDA clearance is for a version of the Rover using a digital Flat Panel Detector and imaging processing software system supplied under a deal with Utah-based company Varex Imaging Corporation, and allows Micro-X to market Rover under its own brand around the world.
“This is a huge step forward for Micro-X now to have its own branded, wholly-controlled, entire x-ray imaging system and now FDA clearance to sell this in the USA,” says Micro-X Managing Director Peter Rowland.
“We can now offer this new version of the Rover product globally and this complete imaging package moves us higher up the value chain.”
Micro-X now has agreements for distribution of the Rover across the US and Europe, including a company which specialises in sales to the US Department of Defense-owned Veterans Affairs hospital network.
Micro-X has revolutionised the mobile x-ray machine market by reinventing how X-rays are generated.
Whereas a so-called mobile X-ray machine in hospitals weigh 400 to 600 kg, Rover is just 95 kg thanks to the company’s patented carbon nanotube X-ray cold emitter technology.
Not only are Micro-X devices much lighter, they produce a beam that can be controlled instantly and precisely by simply adjusting the voltage.
Rover was originally developed under a contract with the Australian Department of Defence to prove Micro-X technology could provide a battlefield-ready medical imaging solution.
The Varex ‘Nexus DR’ detector and software platform gives state-of-the-art image quality for Rover.
“It is lightweight, durable and easy to use. We see this new Rover product offering as being very competitive in the marketplace,” says Rowland.