Echo IQ addresses FDA feedback on EchoSolv HF

• Echo IQ received a not substantially equivalent determination from the US FDA for its EchoSolv HF application.
• The company's share price came to 0.57% following the regulatory announcement.
• Echo IQ plans to address statistical validation issues through options like an administrative appeal or a new submission.

Echo IQ (ASX:EIQ) has commenced work to resolve statistical analysis feedback from the US FDA following a not substantially equivalent decision for its EchoSolv HF application.

The regulatory response comes after the market anticipated progress on the medical technology company's clinical clearance pathway.

The company stated that the FDA raised no concerns regarding the underlying technology or core functionality of the EchoSolv HF device.

Multiple pathways remain under evaluation to secure clearance, including an administrative appeal, an Ombudsman review, or submitting a new 510(k) application.

Echo IQ stated that it believes clearance remains achievable over coming quarters without impacting existing strategic partner agreements.

Following the announcement the Echo IQ share price came to $0.57.

The Sydney-based medical technology firm develops artificial intelligence tools designed to assist clinicians in detecting structural heart disease.

Echo IQ maintains access to large-scale clinical echocardiographic datasets to support its commercialisation and regulatory initiatives.