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Home » SARS-CoV-2

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

Antibodies fighting coronavirus

Advamed’s Van Meter says COVID-19 antigen testing ramp-up on the short horizon

April 22, 2020
By Mark McCarty
The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.
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Regulatory front for April 22, 2020

April 22, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Predictive Technology Group, SC Worx, Spectrum DNA.
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Regulatory action for April 22, 2020

April 22, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Life Spine, Mobidiag, Seegene.
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Other news to note for April 22, 2020

April 22, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aetion, Akili, Aptar, Avacta, Bioclinica, C3.ai, CDISC, Centerline Biomedical, Cole Medical, Cotiviti, Cytiva, Cytosmart Technologies, Entopsis, Federated Healthcare Supply Holdings, Florio, Genetics Institute of America, Healthverity, Horizon Discovery Group, Icecure Medical, Intraop Medical, Itamar Medical, Livanova, Maccabi Healthcare Services, Medtronic, Milestone Scientific, Mimedx Group, Mts Medical Technology, Nexa3D, Nuritas, Qualtrics, Quotient, Sonmol, Sono-Tek, Trividia Health, Vivalnk.
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China remdesivir studies halted due to lack of new COVID-19 patients

April 21, 2020
By Jennifer Boggs
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing.
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U.S. FDA headquarters

FDA gives Labcorp the nod for Pixel home collection swab, but access limited for now

April 21, 2020
By Mark McCarty
The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.
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Regulatory action for April 21, 2020

April 21, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainlab, Inspire Medical Systems, Labcorp, Roche.
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Other news to note for April 21, 2020

April 21, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advarra, Amc Health, Archerdx, Centogene, Cerus, Curetis, Evicore Healthcare, Karolinska Institutet, Kurin, Opgen, Oxford Immunotec, Premier, Science 37, Simplify Medical, Vizient.
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Coronavirus vs U.S. wrecking balls

Administration’s outpatient-first policy should aid cardiovascular, orthopedic implants

April 21, 2020
By Mark McCarty
The Trump administration has proposed a policy to gradually reopen the U.S. for business, part of which is to allow a resumption of elective procedures and treatments in outpatient settings. While patients with urgent medical needs presumably are being treated already, the policy would seem to promise a boost in volumes for certain devices, such as coronary artery stents, knee implants and transcatheter aortic valve replacement (TAVR) devices, all of which enjoy at least limited Medicare coverage for outpatient use.
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Ortho-vitros-antibody-blood-test.png

Ortho Clinical Diagnostics scores win with total antibody test for COVID-19

April 20, 2020
By Liz Hollis
The COVID-19 pandemic has moved rapidly over the past few weeks, and Ortho Clinical Diagnostics Inc. is doing its part to help during the crisis. To that end, the Raritan, N.J.-based company has worked to successfully secure an emergency use authorization (EUA) for its total antibody assay for COVID-19, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and calibrators.
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