Artrya (ASX:AYA) submitted a 510(k) application to the US Food and Drug Administration (FDA) for its Salix Coronary Plaque module, which enables near real-time, point-of-care detection of coronary plaque, according to a Monday filing with the Australian bourse.
The company expects US FDA clearance in the third quarter of the year, the filing said.
Upon approval, the module will qualify for reimbursement worth $950 per assessment, the filing added.
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