Looks and smells like a RHT FDA approval coming , highly unlikely anything other than approval for a fully automated artificial software tool creating a massive market , good luck investors ,it was worth the wait, a $300 million plus market cap or 65C per share is justified .
https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510ks
6th April 2020 ,
Resonance Health Ltd (ASX: RHT) (“Resonance Health” or “Company”announces that its 510(k) application for regulatory clearance by the United States Food and Drug Administration (“FDA”
for the Company’s newly developed AI solution, HepaFat-AI, has been submitted to the FDA. HepaFat-AI is a fully automated artificial intelligence (AI) software tool that measures a patient’s volumetric liver fat fraction (liver fat).
HepaFat-AI can be deployed in the cloud or on premises and can be integrated directly into existing radiology workflows.
HepaFat-AI may be suitable to aid in a patient’s management of several conditions, including fatty liver disease (see Annex A), monitoring the liver-fat content in patients undergoing weight loss management, and aiding in the assessment and screening of living donors for liver transplants.
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