The US Food and Drug Administration (FDA) has issued Emergency Use Authorisation (EUA) for the first serology point-of-care test for Covid-19. The test, Assure‘s Covid-19 IgG/IgM Rapid Test Device, previously received authorized for emergency use by certain labs in July to detect those who developed SARS-CoV-2 antibodies, which indicates recent infection. The FDA has now resissued the EUA to approve the test for POC use with the use of fingerstick blood samples.
PurpleSun has introduced its PurpleSun E300 system which uses Focused Multivector Ultraviolet (FMUV) light technology to disinfect within 90secs. The PurpleSun E300 can be used to disinfect equipment and rooms as the people inside continue to work around the system safely. PurpleSun has also partnered with Hackensack Meridian Health and Northwell Health to provide government agencies with the decontamination technology.
Vela Diagnostics has received the an EUA from the FDA for its ViroKey SARS-CoV-2 RT-PCR Test v2.0. The test is an automated probe-based reverse transcription PCR test that can identify the Covid-19 causing SARS-CoV-2 virus in nasopharyngeal and oropharyngeal swabs. CLIA certified laboratories in the US can use the test to detect Covid-19.
CapsoVision has announced that US Food and Drug Administration will provide enforcement discretion to permit the use of CapsoCam Plus small bowel capsule endoscope for patients amid the Covid0-19 pandemic. With this addendum, fully remote capsule endoscopy procedure can be carried out for eligible patients who are monitored at home. This will eliminate the need for in-person interaction which reduces the risk of infection.