Sydney-based AI and medical technology company Echo IQ (ASX: EIQ) has announced the commencement of its clinical validation study for EchoSolv HF, a heart failure clinical decision support software. Echo IQ uses AI-driven technology and proprietary software to improve decision making in cardiology. The study is being conducted in collaboration with the Mayo Clinic Platform, a division of the Mayo Clinic, a leading US hospital.
The validation study will be performed in conjunction with Mayo Validate, an AI evaluation program that assesses the accuracy, efficacy, and potential biases of AI-based decision software. The commencement of this study aligns with the company’s previous guidance and follows extensive collaboration between Echo IQ and the Mayo Clinic Platform to define study parameters and finalise the protocol.
The initiation of the Mayo Validate study follows the successful completion of the FDA pre-submission process for EchoSolv HF. This study represents the final regulatory requirement before the formal submission to the FDA. Data obtained from the study is expected to validate EchoSolv HF’s ability to detect heart failure using an independent dataset, which will be crucial for supporting Echo IQ’s FDA 510(k) application for the US market.
According to Echo IQ, heart failure represents a significant market opportunity, being the leading cause of rehospitalisation in the US and accounting for 17% of all healthcare expenditure, with an estimated market size of US$60 billion per annum. Echo IQ remains confident of securing FDA clearance for EchoSolv HF during the second half of calendar year 2025.
