Formal Lodgement of FDA Submission for EchoSolv HF

Formal Lodgement of FDA Submission for EchoSolv HF

AI and Medical Technology Company Echo IQ Limited (ASX: EIQ) (“Echo IQ” or “the Company”) is pleased to confirm the formal lodgement of its market clearance application for EchoSolv HF, its heart failure clinical decision support software, via the US Food & Drug Administration’s (“FDA”) 510(k) premarket notification pathway. The submission incorporates results from a clinical validation study conducted specifically to support the 510(k) application.

Read the Full Release