The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ariosa Diagnostics, Illumina, Transmedics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic, Neural Fiber Optic Systems, Medx Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Extracts, Arima Genomics, Asuragen, Aytu Bioscience, Becton, Dickinson and Co., Biogx, Blue Earth Diagnostics, Bracco Imaging, Caredx, Cefaly, Co-Diagnostics, Datos, Geacom, Haselmeier, Healthcall, Heiq Materials, IDbyDNA, Illumina, Impulse Dynamics, Invo Bioscience, Nobio, Pharmajet, Qiagen, Roche, Supergum, Tandem Diabetes Care, Twist, West China Hospital, XCR Diagnostics.
“We look forward to the day where we can get back to normal,” U.S. President Donald Trump said Monday at a COVID-19 news conference in which reporters sat every-other-seat apart. In an unusually somber tone, the president said it now looks like it will be at least July or August before the outbreak “washes through.”
The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein in a March 14 note. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand.
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