Blackbriar Regulatory Services (BRS) has announced its entry into the manufacture of medical devices and production of face masks to help tackle the Covid-19 pandemic. BRS aids small and mid-sized companies to introduce the US Food and Drug Administration (FDA)-approved products into the market, and also offers regulatory and scientific services. It stated that it has wide-ranging manufacturing experience in the highly regulated industries and understands the product requirements of the FDA.
Lord Global Corporation has partnered with KeyOptions to market the Virolens testing unit in other markets. Lord Global received the rights to market it in Australia, Latin America, South East Asia, Turkey and other territories along with other partners. The Virolens system is a screening device for Covid-19 which is based on microscopic holographic imaging and artificial intelligence (AI) software technology. It analyses the saliva samples using a digital camera attached to a microscope.
XIFIN has announced that it will work with laboratories to respond to the need for more testing and technology to handle the testing with the introduction of its cloud-based laboratory information system, XIFIN LIS 7. The platform is equipped with new features which support high complexity, high volume labs, such as integrated speech recognition.
The FDA has added Todos Medical’s TODOS 2019-nCoV RT-qPCR Detection Kit to the Notified List under the Emergency Use Authorisation (EUA) programme. With this addition, the company needs to submit an application for the EUA to the FDA within 15 days after the notification is submitted. Currently, the test is approved to use the QuantStudio 12Flex Instrument to perform the RT-PCR assay. The initial shipments of test kits to the CLIA laboratory clients is expected to commence next week.