Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerus, Ortho Clinical Diagnostics, Profound Medical.
Keeping you up to date on recent developments in cardiology, including: Remote help to lower BP, control cholesterol; Improving screening for dual heart disease; Candidate shows promise in reducing heart failure.
LONDON – The Google artificial intelligence company Deepmind has developed an algorithm that can predict the 3D structure of a protein from its amino acid sequence, making it possible to solve the structures of proteins, such as G-protein coupled receptors (GPCRs), which are a mainstay of drug targeting but whose structure is challenging to determine with current methods.
HONG KONG – Singapore-based X-Zell Biotech Pte. Ltd. has emerged as the winner of the Medtech Innovator Asia Pacific 2020 Accelerator program, as determined by a live virtual audience vote. Winning the competition, organized by Medtech Innovator and the Asia Pacific Medical Technology Association (APACMed), earned X-Zell a $150,000 non-dilutive grand prize to advance its business goals and mission.
LONDON – Long-awaited guidance on the EU regulation for in vitro diagnostics (IVD) that comes into force in May 2022 arrived as the industry increased its calls for implementation to be postponed, citing the extent to which the COVID-19 pandemic has derailed work on bringing products into compliance with the new rules.
Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and RenalytixAI, has received emergency use authorization from the U.S. FDA for its semi-quantitative SARS-CoV-2 IgG antibody test kit. Known as COVID-Seroklir, the test determines the presence and precise level of IgG antibodies. It has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.