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BioWorld - Monday, April 27, 2026
Home » Topics » Coronavirus, Medical technology

Coronavirus, Medical technology
Coronavirus, Medical technology RSS Feed RSS

3-23-Cepheid-GeneXpert-SARS-CoV-2.png

Cepheid gets FDA nod for EUA 45-minute coronavirus test

March 23, 2020
By Meg Bryant
The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes.
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Regulatory front for March 23, 2020

March 23, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Arthrex Inc., Smith & Nephew Inc.
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Coronavirus punch
Bio-Europe Spring 2020

Moving in record time, industry, government, investors focus on one mission: Beat COVID-19

March 23, 2020
By Karen Carey
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
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3-23-Ava-Bracelet-App.png

Fertility wearable to double as COVID-19 temp monitor, as need for population data intensifies

March 23, 2020
By Stacy Lawrence
Zurich-based startup Ava Science Inc. recently issued a public call for partners and funding to further research the potential usefulness of its fertility wearable, known as Ava Bracelet, during the COVID-19 pandemic.
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3-23-Alivecor-KardiaMobile-6L.png

Alivecor’s Kardiamobile 6L joins COVID-19 fight to detect QT prolongation

March 23, 2020
By Liz Hollis
With an eye toward helping those potentially suffering from COVID-19, Mountain View, Calif.-based Alivecor Inc. said its six-lead electrocardiogram (ECG), known as the Kardiamobile 6L, now is allowed for use in the measurement of a patient's QTc and detection of QT prolongation. The Kardiamobile 6L enables patients to take a six-lead ECG outside a doctor’s office.
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Microscope

Biomedical R&D takes hit as university labs, trials shut down due to COVID-19

March 23, 2020
By Nuala Moran
LONDON – COVID-19 excepted, biomedical research projects and clinical trials are grinding to a halt across Europe, as universities shut down and administrators stop any work not related to the coronavirus.
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Antibody

Celltrion reaches milestone on COVID-19 super antibody

March 23, 2020
By Gina Lee
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
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Coronavirus test tubes

Atomo Diagnostics readies AU$30M IPO to ramp up manufacturing of COVID-19 rapid self-test

March 23, 2020
By Tamra Sami
PERTH, Australia – Australia’s Atomo Diagnostics Pty. Ltd. is preparing to raise AU$30 million (US$11.7 million) in an initial public offering on Australia’s Securities Exchange (ASX) that will enable it to ramp up manufacturing for rapid self-tests for COVID-19. The Sydney-based company is working with several multinational diagnostics companies to develop the new COVID-19 blood tests, which would be integrated with Atomo’s existing rapid test platform currently used for HIV screening.
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Regulatory front for March 20, 2020

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

March 20, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genmark Dx.
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