The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push is now on several relatively novel points of emphasis, including high-throughput testing, a technology that may prove critical to corralling the SARS-CoV-2 virus when flu season arrives later this year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Babson Diagnostics, Circadia Health, Ekso Bionics, Medtronic, Nyxoah, Viraxclear.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1Health.io, Cylera, Dentsply Sirona, Ebb Therapeutics, Edge Endo, Global Wholehealth Partners, Hamilton Health, Hi-Clearance, Joimax, Labcorp, Neovasc, Pharmaceutical Product Development, Pri·Med Medical Products, Royal Philips, Physiq, Sequana Medical, Sleepscore Labs, Stevanato Group, The Abedgraham Group, US Endodontics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Dayzz, Elixir Medical, InspireMD, Medtronic, Sintx Technologies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: EMD Serono, Genprex, Medivir, Merck, Sinovac, Tizona, Viracta.
LONDON – Illumina Inc. has named the first three U.K. genomics startups to be backed by its accelerator program, after expanding the scheme from the San Francisco Bay Area to its European headquarters in Cambridge, U.K.
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