Ann: PRE-SUBMISSION MEETING WITH US FDA FOR HEART FAILURE, page-20

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    They achieved 501(k) FDA Approval for Echosolve AS in Oct 2024 which is a decision support aid in the detection of severe Aortic Stenosis
    They are about to lodge the application for Echo Solve HF which is for Heart Failure.

    There is a separate product and FDA clearance for each structural heart condition.

    You should read through the company announcements over the past year to get a clearer picture.

    Hope this helps.
 
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