Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diadem, Endo Tools Therapeutics, Microport CRM, Neurometrix, Seegene, Vuze Medical.
In a speech on Jan. 13, President Joe Biden revealed plans to purchase an additional 500 million at-home COVID-19 tests, bringing the total number the administration expects to provide for free to American households to 1 billion. In addition, Biden said the administration would distribute free “high quality masks.” On Wednesday, the administration said it would provide 5 million rapid COVID-19 tests and 5 million lab-based PCR tests to schools each month to support screening testing and test-to-stay programs.
LONDON – A population level study tracking every pregnancy in Scotland between the start of the pandemic in March 2020 and the end of October 2021 lays bare the devastating impact of COVID-19 on perinatal mortality.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Caredx, Castle Biosciences, Electrocore, Glaukos, Pictor.
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
LONDON – T cells generated as a result of infection with common cold coronaviruses provide cross-protection against being infected with SARS-CoV-2, according to a new study.
Just as the world appeared to be winning the battle against COVID-19, the rules of the game changed. Omicron and concerns about future variants flipped the board. Vaccines and monoclonal antibodies are attracting fresh scrutiny as SARS-CoV-2 evolves. Cases are climbing closer to the highest levels recorded since the pandemic began. Antivirals are aiming to fill treatment gaps, but whether they will or not is about as clear as the virus’ next move.
