14 April

CytoSorbents Corporation has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the use of CytoSorb blood purification technology in Covid-19 patients. With the approval, CytoSorbents will provide CytoSorb to the US hospitals via commercial sales. The technology will be used in patients older than 18 years who tested positive for Covid-19 and are in the intensive care unit (ICU).

An Accurate Diagnostic Labs and Rutgers University joint venture has received the first EUA from FDA for saliva testing for Covid-19 patients. The test, which uses the DNA 1000 Saliva Collection Kit by Spectrum Solutions, permits quarantined or self-isolated people to self-administer sample collection under the supervision of a trained health professional. This should reduce the exposure of Covid-19 to healthcare professionals and patients.

Braun Medical has received the Emergency Use Authorization (EUA) from the FDA for the use of its Perfusor Space Syringe Infusion Pump, Infusomat Space Volumetric Infusion Pump and Outlook ES Pump systems for Covid-19 patients. The systems help in the tracheal delivery of continuous nebulized medications into a nebulizer. They will now be utilised in the treatment of patients who have tested positive for Covid-19. This is expected to decrease healthcare providers’ exposure to the disease.

Biotech company BD has received an EUA for another molecular diagnostic test for Covid-19, which produces results in two to three hours. The test is also CE marked to the IVD Directive (98/79/EC). Based on the assay design of CDC, the test will be carried out on the BD MAX System and is in addition to the other tests developed in collaboration with BioGX and CerTest.

Open platform developer Origin has collaborated with the Beth Israel Deaconess Medical Center (BIDMC) to develop an improved solution for the manufacture of Covid-19 test swabs. Origin, which deals with additive mass manufacturing, has reallocated its resources to transform into a medical device manufacturer from a 3D printer manufacturer.

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