Alexander Najarian

Morrison & Foerster LLP

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Latest Posts › Medical Devices

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CTA Publishes New Standard For Healthcare AI

In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently...more

5/11/2021 / ANSI , Artificial Intelligence , Food and Drug Administration (FDA) , Medical Devices , Medical Software , Technology Sector

FDA Inspires Modifications And Quick Authorizations For Ventilators

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical...more

3/31/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies

Prep Act Declaration Emboldens Drug And Device Industry To Innovate In The Face Of A Growing Crisis

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public...more

3/24/2020 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Immunity , Life Sciences , Medical Devices , Pharmaceutical Industry , Public Readiness and Emergency Preparedness Act (PREP Act)

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