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Home » SARS-CoV-2

Articles Tagged with ''SARS-CoV-2''

Regulatory actions for April 20, 2020

April 20, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Endospan, Fosun Pharma, Foundation Medicine, Genosensor, Osang Healthcare.
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Regulatory front for April 20, 2020

April 20, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory actions for April 17, 2020

April 17, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cirrusdx, Curative, Vent Multiplexor.
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Other news to note for April 17, 2020

April 17, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Biosystems, Assistek, Chronically Simple, Debiotech, Genetic Technologies, Gold Standard Diagnostics Group, Inform Diagnostics, Intelligent Fingerprinting, Kraig Biocraft, Masimo, Medmira, Promega, Qventus, Roche, Rxmx, Samsung, Sanvello, True Diagnostics, Veracyte, Veravas.
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Digital illustration of U.S., coronavirus

Policymakers seek big data’s help with COVID-19, but mobile device collection raises concerns

April 16, 2020
By Mark McCarty
A recent Senate hearing raised the question of whether privacy and confidentiality are at risk when software is installed in smart devices for disease surveillance purposes, but there may be no absolute guarantee of confidentiality, jeopardizing the goodwill of citizens who are wary of big government.
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Abbott-ID-now.png

Abbott beats revised expectations for quarter, sees launch of COVID-19 tests

April 16, 2020
By Liz Hollis
Despite challenges associated with the ongoing COVID-19 pandemic, Abbott Laboratories saw its first-quarter revenue beating expectations, coming in at $7.73 billion vs. an expected $7.44 billion. Cowen’s Josh Jennings highlighted this result, adding in a note that while there are challenges for nondiabetes medical devices and core diagnostics, areas including diabetes, nutrition, the established pharmaceuticals division and COVID-19 testing shined.
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Other news to note for April 16, 2020

April 16, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accelerate Diagnostics, Aranet, Beyond Air, CDC, Biobeats, Biocheck Biofourmis, Co-Vents, Co-Diagnostics, Microsoft, Electronic Caregiver, Elucid Bioimaging, Gaido Health, Huma, Immunecyte Life Sciences, MD Revolution, Milestone Scientific, Moleculight, OralDNA Labs, Proximo Medical, Renesas Electronics, Takeda Pharmaceuticals, Thermogenesis Holdings, Tlt, Vayyar, Vyaire Medical, Xenex Disinfection Services.
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Respiratory infection

FDA’s Stenzel: EUA for COVID-19 home collection sample kit will happen ‘very soon’

April 15, 2020
By Mark McCarty
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
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Regulatory actions for April 15, 2020

April 15, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Behold.ai, Chembio, Nova Biomedical, Ortho.
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In the clinic for April 15, 2020

April 15, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cytosorbents, Nanostring, Pathnostics.
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