medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
20 September Status of administered COVID-19 doses across the globe As of 20 September, 43.3% of the world population has received at least one dose of COVID-19 vaccine. 5.05 billion doses have been administered globally and 28.87 million are now…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Other news including on vacinnes, treatments, trials and side effects, here. Company(ies)/Others Product Issuing regulatory agency or organisation…
A new, sensitive COVID-19 test produces sample-to-signal in under ten minutes. Researchers from the University of Birmingham have confirmed the speed, accuracy and simplicity of a novel, highly sensitive testing method for COVID-19 that can be deployed at entertainment venues,…
An Artificial Intelligence (AI) powered device able to detect SARS-CoV-2 (the virus that causes COVID-19) within 20 seconds is currently under UK MHRA assessment. What is the test called? The device is called SpectraLIT. Who has developed this test? The SpectraLIT device…
The EU Strategy on COVID-19 Therapeutics delivered an announcement from the EU commission on the first portfolio of five therapeutics that could soon be available to treat patients across the EU. Monoclonal antibodies The four newly developed monoclonal antibodies under…
Roche has been granted a CE mark for its SARS-CoV-2 Antigen Self Test Nasal for rapid at-home testing. About the SARS-CoV-2 Antigen Self Test Nasal The test enables individuals to quickly and conveniently test themselves for COVID-19 at home using a simple…
Breathonix, a startup from the National University of Singapore (NUS) has received local approval for its rapid breath test for COVID-19. The test is designed to detect Covid-19 and provide accurate results within one minute. The BreFence Go COVID-19 breath…
Originally posted: 2 May 2021 Last updated: 23 May 2021 Will IPR (Intellectual Property Rights) be the overwhelming factor in deciding the outcome of the pandemic? The answer to this question will likely evolve over the coming weeks and months.…
The European Medical Devices and Coordination Group (MDCG) has endorsed a notice on the impact of genetic variants on SARS-COV-2 IVD medical devices. The notice (MDCG 2021-7) is addressed to manufacturers and authorised representatives of in vitro diagnostic medical devices (IVDs) with…
Researchers at the University of Waterloo in Ontario are working with a company called ChitoLytic Inc. to develop an at-home saliva test for COVID-19 that can be ready in 20 minutes. How does the test work? It works by placing…