SHL Telemedicine files pre-submission with FDA for Over the Counter clearance of SHL’s SmartHeart™ full 12 Lead ECG

Tel Aviv/Zurich, 12 January 2021 – SHL Telemedicine Ltd. (SIX Swiss Exchange: SHLTN) (“SHL” or the “Company”), a leading provider and developer of advanced personal telemedicine solutions, announced today that it has filed a pre-submission with the US Food and Drug Administration (FDA) for Over the Counter (OTC) use of its SmartHeart™ full 12 Lead ECG. SmartHeart™ is already FDA cleared and marketed in the US as a „prescription only“ device.

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