Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Cae, Candela, Enexor Health, Foundation Medicine, Tandem Diabetes Care.
A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore.
Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bimini Health Tech, Binx Health, Cardinal Health, Copan, Cymedica Orthopedics, Debiotech, Exthera, Genmark Diagnostics, Healeon Medical, Healgen, Hill-Rom, Inovalon, Kardiac Devices, Keystone Heart, Kore, MD Anderson Cancer Center, Menarini, Neokidney, Ngmedical, Nicoya, Philips, Puritan, Second Sight, Svenska Labfab, Trialspark, Venus Medtech, The Wound Pros.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Exact Sciences, Halo Diagnostics, Lucence, Medtronic, Sequana Medical.
DUBLIN – Etherna Immunotherapies NV raised €34 million (US$38.2 million) in a series B funding round to progress its pipeline of mRNA-based vaccines for cancer and infectious disease.
LONDON – In the first major breakthrough in therapeutics for COVID-19 infection, dexamethasone has been shown to have a statistically significant impact on mortality in the most seriously ill patients.
Policymakers in the U.S. are grappling with a disastrous pandemic as well as long-standing political tensions, but one aspect of the COVID-19 pandemic that might unify them is the need to ensure that patients in the U.S. are not at the mercy of other nations for needed diagnostics and therapies.
