Australian technology company Micro-X (ASX: MX1) has obtained early approval from the United States Food and Drug Administration (FDA) to sell its Rover mobile medical x-ray device in the US.
The company lodged its 510(k) submission for the Rover product on 10 June and received clearance as a Class II medical device in just five weeks instead of the FDA’s usual 90 calendar day turnaround.
Micro-X’s Rover product was originally developed under a contract from the Australian Department of Defence to prove the company’s technology could fulfil an unmet need for a full performance, digital, medical x-ray imager that was light enough to be used in deployed military medical hospitals.
According to Micro-X, the Rover weighs 95kg and offers the higher power needed for trauma imaging that previously only conventional technology units more than five times the weight could provide.
The product has also been purposely designed for military operations, featuring increased ground clearance, battery endurance and other enhancements for operating in rugged terrain.
Second commercial launch in the US
The Rover is Micro-X’s second commercial product for the US market, following its Carestream DRX Revolution Nano digital medical x-ray system which already holds both 510(k) and CE Mark (Europe) certifications.
Micro-X managing director Peter Rowland described the Rover’s FDA clearance as a “hugely exciting milestone” for the company.
“We can now start full marketing and demonstration activities of this unique product to the US Army, Navy and Air Force,” he said.
Micro-X said it has already been engaged in active talks with the US Army Medical Material Agency for “some time”.
“As the only deployable product with this full x-ray performance, our focus is now on ramping up sales and commercialisation activities in the US to convert the interest into sales,” Mr Rowland added.
Direct sales channel
According to Micro-X, Rover’s commercialisation will be conducted through the company’s direct sales channel to enable greater control of the sales process and better margins than using distributors.
The direct sales model will focus on the US, Australia, the United Kingdom and other North Atlantic Treaty Organization (NATO) countries with an addressable market size exceeding $170 million.
The company said it plans to seek CE Mark and Therapeutic Goods Administration (TGA, Australia’s medical device regulatory body) registration “within the next 12 months”.