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.
BEIJING – One more company is joining the global efforts in developing a vaccine for COVID-19. Beijing-based Yisheng Biopharma Co. Ltd. unveiled YS-SC2-010, which was developed through recombinant protein technology and its proprietary PIKA (polyinosinic-polycytidylic acid-based adjuvant) technology.
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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Endologix, Klarity, Supernus, United Therapeutics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clew, Guard Medical, Infinity, Inmode, Smith+Nephew.
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.
CAJICA, Colombia – A team of scientists in Argentina is working on obtaining monoclonal antibodies from hens and llamas in a bid to produce both a vaccine and a drug for SARS-CoV-2, but the development process is highlighting the challenges that researchers and scientists in developing countries with troubled economies can face.
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