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. Read More
A new sensor developed by The Charles Stark Draper Laboratory Inc. measures your bioelectrical field. It may sound like “polishing your aura” but, in reality, it stands to be the most significant transformation of the electrocardiogram in decades. The sensor adapts technology developed for navigation and guidance systems to provide three-dimensional (3D) measurement of the heart's bioelectric field. Read More
Data from a newly published case series underscores the effectiveness of Cytosorbents Corp.’s blood purification technology in treating critically ill COVID-19 patients. Read More
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. Read More
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. Read More
BioWorld's offices will be closed in observance of Thanksgiving in the U.S. No issue will be published Thursday, Nov. 26, or Friday, Nov. 27. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acarix, Applied DNA, Co-Diagnostics, Corticometrics, Kantaro, Rapidrona. Read More
Keeping you up to date on recent developments in orthopedics, including: Potential cellular target for eliminating bone breakdown in osteoporosis found; Popular weight-loss surgery in teenagers weakens bones; Study: Early, late stages of degenerative diseases are distinct. Read More
