Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs). The Sentosa SQ HIV-1 Genotyping Assay – the first HIV-1 genotyping next-generation sequencing (NGS) assay to win an FDA nod – uses plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase and integrase regions of the pol gene in a single test. Read More
The U.S. FDA has approved the Senza Omnia Spinal Cord Stimulation (SCS) system from Redwood City, Calif.-based Nevro Corp. The system is the first such system that delivers Nevro's high frequency 10,000 Hz stimulation, known as HF10, but also all other therapeutic spinal cord stimulation frequencies. Read More
The first day of the FDA's two-day hearing on ethylene oxide (EtO) sterilization of medical devices addressed several alternatives to EtO, but the advisory panel had little advice to offer the agency other than to encourage tweaks to sterilization procedures in order to get past the immediate problem. Read More
LONDON – The EU's next large-scale public-private research partnership in health is taking shape and due for launch at the start of 2021, succeeding the current €3.6 billion (US$4 billion) Innovative Medicines Initiative 2 (IMI2). Read More
PARIS – A French research consortium bringing together the firm Cap Gemini SE, the Traumabase (traumabase.eu) network, the AP-HP group of 39 teaching hospitals in the Paris region, the École Polytechnique, the National Center for Scientific Research (CNRS) and the Ecole des Hautes Etudes en Sciences Sociales (EHESS), is developing the first AI decision-making tool for managing patients with severe trauma in their first 24 hours. Read More
For more than two decades, the BioWorld team has understood that there's a vital need to know to stay competitive, to bring your novel ideas forward through the long cycle of development, testing and commercialization. Now we've upgraded our presentation of news and analysis. On Nov. 19, we're migrating to a fantastic new platform. Read More
