FDA Authorizes a COVID-19 Diagnostic Test for Asymptomatic Individuals

One of the challenges in controlling the rate of new infections during the COVID-19 pandemic has been the lack of a diagnostic test specifically indicated for asymptomatic patients. According to some estimates, nearly 40% of the new cases of SARS-CoV-2 infections do not have any visible symptoms. As a result, many of those infected are not aware they are carrying the virus and may be inadvertently adding to the rising rates of new infections. A newly authorized diagnostic test for asymptomatic patients could help.

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.

FDA Unlocks the Key to Innovation in Interoperable Medical Devices

Interoperability holds the key to interconnected medical devices. A recent De Novo classification of a software for diabetes management shows the way forward.