Echo IQ Appeals US FDA Decision on EchoSolv HF; Shares Up 8%
MT Newswires Live
Oct 12
Echo IQ (ASX:EIQ) filed an administrative appeal challenging the US Food and Drug Administration's (FDA) decision that its EchoSolv HF device is not substantially equivalent for 510(k) clearance, according to a Monday Australian bourse filing.
The appeal has been accepted, and the US FDA Ombudsman has been duly notified, per the filing.
The company expects to gain greater clarity on EchoSolv HF's regulatory pathway following an FDA meeting anticipated within the next 30 days, the filing added.
The company's shares rose 8% in recent Monday trade.
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