05/11/2020 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 5/11/2020. This two-page fact sheet informs healthcare providers of the significant known and potential risks and benefits of the emergency use of the Eko ECG Low Ejection Fraction Tool (ELEFT). This software device for diagnosing low Left Ventricular Ejection Fraction (LVEF) is for use by healthcare professionals (HCP) to provide an assessment of LVEF for use as a diagnostic aid to screen for potential cardiac complication associated with COVID-19 or underlying cardiac conditions that may affect clinical management of COVID-19, in adult patients having or suspected of having COVID-19. (PDF)
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