A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. The FDA has just approved a new antiviral drug, Remdesivir from Gilead Sciences, for treating COVID-19 patients needing acute care in a hospital. This treatment was available until now under an Emergency Use Authorization (EUA), but a full FDA approval will facilitate broader use.
Read MoreRecently, several treatment options have become available to treat the most seriously ill COVID-19 patients. Antivirals such as Remdesivir and corticosteroids such as Dexamethasone are now being used to improve the recovery time and mortality rate among hospitalized patients. However, their curative effect against COVID-19 has not yet been established and these treatments are not widely available to the public.
Read MoreOne 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.
Read MoreThere 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.
Read MoreThe 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.
Read MoreSince the onset of the COVID-19 pandemic, there has been a lot of conversation surrounding the shortages of Personal Protective Equipment (PPE). In particular, we hear a lot about face masks and how they can help prevent the spread of COVID-19. But there is a lot of confusion out there - and many strong opinions - both for and against the use of face masks! In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.
Read MoreIndustry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA.
Read MoreGlobal outbreak of the recent novel coronavirus needs an all-hands-on-deck approach. Here is how QA/RA professionals in the medical industry can help.
Read MoreInteroperability holds the key to interconnected medical devices. A recent De Novo classification of a software for diabetes management shows the way forward.
Read MoreRecently, there has been a lot of media attention on safety of medical devices cleared and approved in the U.S. market by the FDA.
Read MoreRecently, I had an opportunity to hear directly from FDA leaders during a fire-side chat at the Xavier Health AI Summit in Cincinnati, OH. Alonza Cruse, Director, FDA - Office of Regulatory Affairs and Bakul Patel, Associate Director, FDA – Center for Devices and Radiological Health, each shared their views on how AI is shaping FDA’s thinking in nearly all of its operations. It was very encouraging to hear that the FDA wants to build a collaborative relationship with the industry and “stand out of your way” to help realize the true potential of AI in Healthcare.
Read MoreZimmer Biomet, one of the leaders in the $50 billion global orthopedic medical device industry, is placing a big bet on this idea! They have just announced a large clinical trial to test their mymobilityTMapp working with the Apple Watch® to see if it can be a viable alternative to the current standard of care after hip and knee replacement surgery. They expect to enroll nearly 10,000 patients in this study over a period of two years.
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