The U.S. FDA moved the goal posts for other companies with its expansion of the emergency use authorization for Helix Opco LLC’s COVID-19 test to include both unsupervised self-collection of samples and testing of asymptomatic individuals. The new indications promise to make the Helix test the preferred tool for schools, universities, and work settings by reducing costs and increasing flexibility.
Virtual Incision Corp. revealed that it had received a green light from the U.S. FDA to begin its study of its miniaturized in vivo robotic assistant (MIRA) Platform. Initially, the company will focus the platform on minimally invasive laparoscopic colon surgery. With the MIRA Platform, the company will aim to enter a growing market in the U.S., where more than 400,000 colon resection procedures are performed each year.
Shares of early cancer detection company Exact Sciences Corp. soared Tuesday morning on news it is acquiring two liquid biopsy screening companies, Thrive Earlier Detection Corp. and Base Genomics Ltd., for $2.56 billion and selling $869 million of common stock to institutional investors.
PERTH, Australia – Neuroscience technology company Cogstate Ltd. and Japanese pharmaceutical company Eisai Co. Ltd. signed a deal under which Eisai will have global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the Cogstate Brief Battery (CBB) for use in health care and other markets.
LONDON – Three large scale population surveys conducted between late June and the end of September have shown the prevalence of SARS-CoV-2 antibodies in England declined by 26.5% over three months. The findings rest on the results of more than 350,000 self-administered lateral flow blood tests that were carried out at home by volunteers who were randomly selected from general practitioner registers.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS provides details of Binax test distribution.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biobeat, Foundation Medicine, Virtual Incision.
Med-tech firms raising money in public or private financings, including: Abm Respiratory Care, Caris Life Sciences, Eucrates Biomedical, Helius Medical Technologies, Intuitive Surgical.
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