PainChek (ASX:PCK) said a meeting with the US Food and Drug Administration (FDA) is scheduled this month to discuss its request for de novo regulatory clearance for the PainChek Adult App, according to a Wednesday filing with the Australian bourse.
The clearance would enable the company to enter the US healthcare market, potentially generating roughly $100 million per annum in aged care, the filing said.
Meanwhile, the company launched its PainChek Infant app on the Apple App Store, now available in Australia, according to the filing.
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