Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alafair Biosciences, Assure Tech, Quadrant Biosciences, Vela Diagnostics.
LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.
Two studies seek to answer the most pressing question for physicians examining a patient with COVID-19: What's this person's risk of death? Mount Sinai researchers presented their clinical prediction model in The Lancet Digital Health and a team from Johns Hopkins published their risk calculator in the Annals of Internal Medicine.
PERTH, Australia – Australian public health laboratories are collaborating to sequence the virus genomes of all positive COVID-19 tests in Australia to track the virus using genomics across the country. The Communicable Disease Genomics Network (CDGN) and Illumina Inc. will track COVID-19 by using next-generation genomic sequencing technology.
Visby Medical Inc. emerged from stealth mode to secure emergency use authorization (EUA) from the U.S. FDA for its Personal PCR device for detection of COVID-19 infections. It is the first FDA-authorized portable device to use the polymerase chain reaction technology for COVID-19 testing. The San Jose, Calif.-based company was known as Click Diagnostics Inc. until March 2020.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Axonics, Simplify Medical, Visby Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Medical Technology Association, Biocept, Boston Scientific, Dariohealth, Decision Diagnostics, Exagen, Gunze, Hancock Jaffe, Highmark, Hmc Healthworks, Icad, Mimedx, Misonix, Novartis, Ortho Clinical Diagnostics, Polarityte, Radiation Business Solutions, Radmax, Royal Philips, Siemens Healthineers, Startx, Titan Medical.
