Micro-X’s Rover gets the green light from the FDA
Health & Biotech
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Portable x-ray manufacturer Micro-X (ASX:MX1) has announced its Rover product has been given FDA 510(k) clearance in just five weeks.
Rover is intended for defence forces that build temporary medical facilities and require portable equipment.
The weight of existing technology, typically five times the Rover’s 95 kilogram weight, meant defence forces previously had to use lower-powered units.
But the Rover is powerful enough to do just what its heavier peers can.
Now with the FDA’s approval, Micro-X intends to sell it in the United States including to the Army, Navy and Air Force.
“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,” Micro-X managing director Peter Rowland said.
While the company won’t be a US-only play — indicating it is seeking Australia and European approval too — it said the US was the single largest market because it had the world’s largest defence budget.
Stockhead has contacted the company for further comment.
Micro-X was surprised with the speed at which the FDA reviewed Rover and signed off on it.
The company told shareholders it had made its case to the FDA back on June 10. The regulator has indicated that the review period typically takes around three months.
But Micro-X got clearance in just five weeks. The company said this recognised the quality of the submission it made — its first ever to the FDA.
This is the second Micro-X product to be given FDA approval, with the first being its DRX Revolution Nano approved back in 2017.
However it was US distributor Carestream that made that first FDA submission and carries its name on the product.
Shares climbed nearly 20 per cent this morning.