Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test manual version has received the CE mark for in vitro diagnostic use. ViroKey SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR test that identifies the presence of the virus by targeting conserved regions in the genome of SARS-CoV-2. The manual version of the assay allows for faster adoption of the test in laboratories equipped with the Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments.
ALung Technologies has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Hemolung Respiratory Assist System (RAS). The system is used to treat patients infected with the Covid-19. FDA said that the Hemolung RAS can potentially be used to treat lung failure, in addition to the use of noninvasive or invasive mechanical ventilation in a bid to decrease the occurrence of hypercapnia and hypercapnic acidosis in Covid-19 patients. The Hemolung RAS is used in the VENT-AVOID trial, which is approved by the FDA. The trial studies the use of ECCO2R to treat Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AE-COPD).
Leica Biosystems has received the additional notification from the FDA about its intention to exercise enforcement discretion when the Aperio WebViewer is used for remote diagnosis. The system will permit the pathologists to view and diagnose cases from remote locations using a computer, which will reduce the exposure to coronavirus.
Newlight Partners has announced that it will provide the CPASS Foundation with 2,000 pulse oximeters and 4,600 digital thermometers to aid seniors amid the Covid-19 pandemic in the US. The CPASS Foundation has collaborated with Oak Street Health and Zing Health to provide supplies to seniors who are at-risk in each state.