The latest global regulatory news, changes and updates affecting medical devices and technologies, including: General Motors, Inbios International, Philips, Ventec Life Systems.
Novavax Inc., one of the first biopharma companies to reveal its efforts to develop a SARS-CoV-2 vaccine in January, has identified a prefusion protein for testing in an Australian phase I trial, slated to start in mid-May.
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. received the CE mark for its 3base Easyscreen SARS-CoV-2 detection kit, clearing the way for marketing across the EU.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acumen Research Laboratories, Allurion Technologies, Almac Clinical Technologies, Artms Products, Beam Therapeutics, Bio-Rad Laboratories, Biotricity, Cure Pharmaceutical, Getinge, Imaginab, Invitae, Ivwatch, James Fisher, The Janz, Medipines, Mesa Biotech, Mirion, Nano-X, Oklahoma State University, Qure.ai, OGT, Parallax, Rapid Medical, United Global Alliance, Vortran, Xerox.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cochlear, Genetron, Gnomegen, Motus GI, Nitiloop, Orthosensor.
Keeping you up to date on recent developments in oncology, including: Technetium crunch resurfaces as COVID-19 roils the globe; Microbiome changes precede tumor development in CRC; Il-27 proposed as target in prostate cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3M, Boston Scientific, Gnomogen, Viracor Eurofins Clinical Diagnostics.
The U.S. Federal Communications Commission (FCC) has received funds for another telehealth program in less than a year. An agency statement indicates that the program “would immediately support health care providers” working to thwart the COVID-19 outbreak. This would be achieved in part by supporting purchases of devices and other items needed to provide telehealth, which the Connected Health Initiative said will help drive an overdue overhaul of health care in the U.S.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Beroni Group, Biogx, Clinical Laserthermia Systems, Leica Biosystems.
