Pre-Submission Meeting with the U.S. FDA Regarding Heart Failure

Echo IQ Limited (ASX: EIQ) is progressing towards gaining FDA clearance for its heart failure screening tool, EchoSolv HF. The company has submitted a formal request to the US FDA for a pre-submission meeting, anticipated in the first quarter of 2025. This meeting aims to finalize the regulatory strategy and protocol for the clinical validation study. Echo IQ expects to receive clearance for EchoSolv HF in the second half of 2025. Recent studies in collaboration with leading Australian research centres have demonstrated the strong performance of EchoSolv HF. The standalone AI detected 86% of heart failure cases, significantly outperforming the 46% detection rate found in standard clinical practice. Furthermore, when the AI was combined with clinical evaluation, the accuracy improved to 97% for high-risk patients.

The proposed validation study will begin next quarter and represents the final step before obtaining FDA clearance. EchoSolv HF addresses a significant unmet need in the United States, where heart failure accounts for 17% of healthcare expenditure and represents an estimated annual market of US$60 billion. Negotiations with prominent US healthcare organizations to support the study are progressing well.

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