COVID-19 Testing – Understanding Antibody Tests

There is a lot of conversation about testing. Antibody tests, also called serological tests, help detect the presence of antibodies in blood samples. Antibody testing, when done at large scale, can help us understand the true rates of infection, mortality rates and level of immunity in the population on a regional basis. That is why these tests are a very powerful tool to help fight this devastating disease.

Regulatory News, Industry NewsNaveen AgarwalJuly 20, 2020covid-19, COVID-19, coronavirus criss, coronavirus crisis, coronavirus pandemic, FDA, FDA regulations, FDA approves coronavirus tests, antibody tests, serological testsComment

FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic

The medical landscape is constantly changing, particularly during the COVID-19 pandemic. With so much happening, there is a lot of confusion, particularly surrounding shortages of Personal Protective Equipment (PPE) and Face Masks. The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. In this article, we will cover Face Shields and Respirators.

Industry News, Regulatory NewsNaveen AgarwalJuly 10, 2020COVID-19, covid-19, coronavirus criss, coronavirus crisis, coronavirus pandemic, FDA, FDA regulation, FDA authorization, FDA News, respirators, N95 masks, face shields, face masksComment

How MedTech is Rising to Help Combat the Coronavirus Pandemic

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA.