Echo IQ (ASX:EIQ) requested a pre-submission meeting with the US Food and Drug Administration (FDA) to confirm the design of a proposed validation trial of its heart failure screening tool, EchoSolv HF, according to a Tuesday filing with the Australian bourse.
The meeting, expected within 90 days, follows two completed clinical studies that showed that EchoSolv HF's artificial intelligence (AI) technology detected 86% of heart failure cases, compared with a 46% detection rate in standard clinical practice, the filing said.
The company aims to use the meeting to confirm its validation study design with the US FDA and expects regulatory clearance for EchoSolv HF in the second half of 2025.
The AI and medical technology company is in advanced talks with US healthcare organizations to conduct the validation study, set to start next quarter as the final step before FDA submission.
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