PriceSensitive

Micro-X (ASX:MX1) receives FDA approval for a new Rover product

Technology
ASX:MX1      MCAP $50.38M
26 May 2021 10:40 (AEST)
Micro-X (ASX:MX1) - CEO, Peter Rowland (left)

Source: Australian Manufacturing Forum

Micro-X (MX1) has received U.S. Food and Drug Administration (FDA) approval for a new version of its medical bedside imaging x-ray unit, Rover.

The hi-tech company has sourced a new digital flat panel detector for Rover through an agreement with independent supplier Varex Imaging.

Varex is a developer and manufacturer of x-ray imaging components and software for the x-ray industry, making around 23,000 imaging detectors annually.

This detector and its associated image processing software will be sold under Micro-X’s own brand giving the company its first complete x-ray product.

The company has been given FDA approval for this new detector and software, taking only 14 days since the application was submitted.

Micro-X will now commence marketing and sales activities of this new version of Rover in the United States.

This approval complements the FDA approval in 2020 with the Fujifilm detector, targeted for military markets.

Managing Director Peter Rowland says this is a huge milestone for Micro-X to now have its own branded and controlled x-ray system.

“Since we ended the exclusivity of our distribution relationship with Carestream
Health, we now have the freedom to offer this new version of the Rover product globally and this complete imaging package moves us higher up the value chain,” he said

“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,” he added.

Just before the market opens this morning, Micro-X is trading at 32 cents per share.

Related News