Author Archive: AZBio

Prisma Health Collaborates with Ethicon Inc., part of the Johnson & Johnson Medical Devices Companies, to Manufacture and Distribute the VESper™ Ventilator Expansion Splitter Device that is Authorized for Emergency Use Only During the COVID-19 Pandemic

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Due to the predicted dire ventilator shortage, Prisma Health received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the device in response to the urgency for more ventilators as a result of the pandemic.

Using 3D printing manufacturing technology, Ethicon will manufacture and distribute the VESper Ventilator Expansion Splitter at no cost to healthcare providers in the United States under the EUA during the current COVID-19 pandemic. The initial distribution of the device will be limited to the United States as Prisma Health and Ethicon are developing strategies to navigate various regulatory pathways and fulfill orders worldwide.
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ASU receives $2M to boost coronavirus rapid research response

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ASU’s Biodesign Institute will utilize Piper Trust support to increase its capacity for automated, rapid diagnostic testing to mitigate the viral spread and potential reoccurrence of COVID-19.

“Now is the time for those who can — individuals and public- and private-sector organizations — to step in quickly and support our nonprofits,” said Mary Jane Rynd, president and CEO of Virginia G. Piper Charitable Trust. “They are serving on the frontlines and are essential to our economic vitality.”
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IMNA Solutions Provides TrialME, a Remote Patient Monitoring and Data Collection Platform to Support Drug Development and Keep Clinical Trials Open During COVID-19 Pandemic

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Starting April 1st, 2020 through July 1st, 2020, IMNA is offering free access to the TrialME platform for all teams researching COVID-19 and other life debilitating diseases.

TrialME offers sites a seamless shift to a hybrid structure that follows the FDA’s new guidelines during COVID-19 pandemic; the platform monitors, engages, and communicates with patients from the comfort and safety of their home. Continue reading→

BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S. New Test Immediately Available to Increase Capacity of Rapid, On-Site Testing of COVID-19 at Hospitals Across the U.S.

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The test helps fill an urgent need across the U.S. for hospitals to access an easy-to-use, rapid diagnostic test to screen patients and health care workers for COVID-19. The test will be run on the BD MAX™ System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. Each unit is capable of analyzing hundreds of samples per day.Continue reading→