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FDA grants Formlabs emergency clearance for 3D-printed ventilator component

The 3D printing company has received federal approval to print adapters designed to convert BiPAP machines into ventilators.
stephanie-condon
Written by Stephanie Condon, Senior Writer on

The 3D printing company Formlabs has received emergency clearance from the federal government to print adapters that can convert BiPAP machines -- typically used to treat sleep apnea -- into ventilators for COVID-19 patients. Formlabs says it's the first 3D printing manufacturer to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration for components related to the pandemic. 

With its EUA in hand, Formlabs will allocate 150 3D printers at its Massachusetts headquarters to printing the small, plastic, T-shaped adapter. The adapters -- designed by Northwell Health, New York's largest healthcare provider -- convert bi-level positive airway pressure (BiPAP) machines into ventilators.  

Formlabs says that once production is fully ramped up, it can print up to 3,000 parts a day. It's already shipping adapters to hospitals across the US. 

Ventilators, used to treat critically-ill COVID-19 patients, have been in short supply, prompting efforts to build more and convert other kinds of medical devices into ventilators. One group of open-source developers is working on firmware to transform Constant Positive Airway Pressure (CPAP) machines -- another device for treating sleep apnea -- into BiPAPs, so they can be deployed as ventilators.   

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LEE S. WEISSMAN/ Northwell Health

In a statement, Formlabs CEO Max Lobovsky said 3D printing is uniquely suited for this moment. 

"Prior to the COVID-19 pandemic, the FDA had only authorized a handful of  EUAs over a 30 year period," he said. "Formlabs' EUA for BiPAP adapters signifies the need for these components and 3D printings' unique ability to fill that need. 3D printing enables rapid iteration and prototyping of new, innovative medical equipment, while expediting the production process, shortening supply chains, and allowing for localized manufacturing."

In addition to printing the BiPAP adapters, Formlabs has been mass-producing COVID-19 test swabs and working on other equipment to aid in the pandemic response. It's one of several 3D printing firms contributing to the effort. 

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