Physicians who perform a variety of device implant procedures face a difficult choice in determining whether a patient should be treated. A new article in the Journal of the American College of Cardiology (JACC) recommends that patients who ordinarily would be candidates for surgical aortic valve replacement (SAVR) might instead be referred for the transcatheter alternative.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cipla, Diacarta, DNAe, Vapotherm, Silk Medical Aesthetics.
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic. Carmen Wiley, president of the American Association of Clinical Chemistry, told BioWorld that the existing instrument types are up to the job, but that surge capacity is needed, and that it is not clear how the cost of that capacity will be handled.
Amid the COVID-19 pandemic, Genmark Diagnostics Inc., of Carlsbad, Calif., has offered a preliminary look at its first-quarter results. And it is forecasting hopeful news, increasing its full-year guidance to a range of $112 million to $122 million. That's up from a previous prediction of $100 million to $110 million.
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.
