Tag: fda
LetsGetChecked raises $71 million as COVID-19 epidemic makes home-testing increasingly vital
As the country wrestles with the COVID-19 epidemic, home health testing, checkups and diagnostics have never been more important and companies like LetsGetChecked are filling a void left in a U.S. healthcare system consumed by the outbreak. The surge in demand for the company’s services has led to an equal…
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FDA clears Formlabs’ 3D-printed BiPAP-to-ventilator converter
In the race to provide the ventilators needed to treat COVID-19, several companies have developed new devices. But there may be a simpler approach. Formlabs has received an emergency use authorization (EUA) from the FDA to 3D-print small adapters tha… Source
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KlearNow raises $16 million to bring customs clearance industry into the digital age
Customs is the sieve of international supply chains. And yet despite its critical role, clearing customs for freight brokers can be a slow and opaque process reliant on manual data entry and prone to errors. Silicon Valley-based KlearNow has developed a platform that aims to bring customs clearance into the…
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NVIDIA’s top scientist develops open-source ventilator that can be built with $400 in readily-available parts
NVIDIA Chief Scientist Bill Daily has released an open-source ventilator hardware design he developed in order to address the shortage resulting from the global coronavirus pandemic. The mechanical ventilator design developed by Daily can be assembled quickly, using off-the-shelf parts with a total cost of around $400 – making it…
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NASA will license its FDA-approved ventilator to manufacturers for free
A new high-pressure ventilator developed by NASA engineers and designed to treat COVID-19 has received FDA approval via a fast-tracked emergency use authorization. Now, NASA is looking for a medical industry partner to manufacture the device. It will… Source
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Spiro Wave emergency ventilator gains FDA authorization to address COVID-19 demand
A new project designed to help address the growing need for ventilator hardware in order to treat the most serious cases of COVID-19 achieved an important milestone today, getting FDA Emergency Use Authorization (EUA) for its units to be used and scaled for production. The hardware, dubbed ‘Spiro Wave,’ is…
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