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BioWorld - Tuesday, February 3, 2026
Home » Topics » Coronavirus, Medical technology

Coronavirus, Medical technology
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Drug vials and syringe

FDA delivers on promise of guidance for vaccine EUAs

Oct. 6, 2020
By Mari Serebrov
Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine.
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Coronavirus, question marks
Virtual Medtech Conference

Industry reflects on the future of innovation as COVID-19 continues to have an impact

Oct. 5, 2020
By Liz Hollis
What is the future of med-tech innovation in the wake of COVID-19? That was the question addressed during the Advanced Medical Technology Association’s Virtual Medtech Conference, with members of industry providing some insight. “I think … that this is going to be in many ways a turning point,” changing the way stakeholders look at devices and the evidence supporting them, said Tom O’Brien, of Johnson & Johnson’s (J&J) Ethicon unit.
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Stephen Hahn, FDA commissioner
Virtual Medtech Conference

FDA’s Hahn on COVID-19 vaccine: ‘Trust the career scientists, trust the FDA’

Oct. 5, 2020
By Annette Boyle
In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials.
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Regulatory actions for Oct. 5, 2020

Oct. 5, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Chembio, Haemonetics, Histosonics, Pixcell Medical, Quidel.
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Other news to note for Oct. 5, 2020

Oct. 5, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Dcao Solutions, Gentex, Icecure Medical, Masimo, Premier, Retispec, Senseonics Holdings, Spineology, Terumo, Vaxxas, Xenocor.
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Product image

Songbird flying high with Health Canada approval of double biomarker COVID-19 test device

Oct. 2, 2020
By David Godkin
TORONTO – Health Canada has approved a portable COVID-19 test kit which began as a testing regime for identifying pathogens, microbes and viruses in the European food and natural products industry. The Hyris Bcube developed by Guelph, Ontario-based Songbird Life Science Inc., in partnership with London, U.K.’s Hyris Ltd., is described as a portable DNA-based “laboratory in a box” for coronavirus testing in large urban spaces as well as more remote, indigenous communities in Canada’s north.
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Coronavirus vs U.S. wrecking balls

Parry and riposte the main theme at House pandemic hearing

Oct. 2, 2020
By Mark McCarty
The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time.
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Regulatory front for Oct. 2, 2020

Oct. 2, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed, Rockefeller Foundation.
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Regulatory actions for Oct. 2, 2020

Oct. 2, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dascena, Labcorp, OralDNA Labs.
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Other news to note for Oct. 2, 2020

Oct. 2, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Artificial Intelligence Defense Platform, Biosense Webster, Curepsp, Diamir, Fti Foodtech International, Lensar, Mentice, Natera, Onlume, Pfizer, Rapid Virus Detect, Relay Medical, Vascular Simulations, Wuhan Easydiagnosis Biomedicine.
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