LONDON – DNA Electronics Ltd. (DNAe) won a U.S. FDA breakthrough device designation for its semiconductor-based DNA sequencing technology Lidia-seq and for the first assay based on the platform, which will detect bloodstream infections and antimicrobial resistance (AMR) genes at point of care.
PARIS – Medical gases specialists Air Liquide SA, of Paris, along with Peugeot SA, Schneider Electric SE and Valeo SA have joined together in a consortium to manufacture ventilators in a time when there is a critical shortage.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cipla, Diacarta, DNAe, Vapotherm, Silk Medical Aesthetics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio-Rad, Boston Scientific, Celsee, Center for Medical Interoperability, Ciox Health, Eclipse Automation, Electrocore, Glaukos, Harmontronics Automation, Labcorp, Lantheus, Markforged, Medtronic, Micron Solutions, Neurophotometrics, Nevro, No Borders, Orthofix, Phase Scientific, Quest.
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.
Specific therapies against a new disease take time to develop. But there are methods that can speed up that development – and in the meantime, there are ways to make do with what’s already in the cupboard.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Athenex, Biohaven, Calcimedica, EMD Serono, Kiadis, Lannett, Pfizer, Viracta.