Formlabs gets FDA emergency use authorization for a 3D-printed ventilator conversion part
The U.S. Food and Drug Administration has awarded Formlabs an emergency use authorization (EUA) for a 3D-printed part designed to convert BiPAP machines designed for sleep apnea into much-needed ventilators. The offering was one of dozens of ventilators and accessories granted such authorization over the weekend.
The company plans to devote 150 3D printers at its Somerville, Mass. plant to producing the part, which it says it will then distribute to hospitals and local governments throughout the U.S.
“Prior to the COVID-19 pandemic, the FDA had only authorized a handful of EUAs over a 30-year period,” CEO Max Lobovsky said in a release. “Hospitals around the country can also use Formlabs’ printers to create these adapters locally under their own practice of medicine, meaning printing the adapters at scale in the hardest-hit areas is as easy as uploading a design and pressing print.”
Formlabs is one of a number of different 3D-printing companies springing into action amid the COVID-19 pandemic. The unprecedented situation has created a number of distinct challenges for which the technology is uniquely suited. Formlabs has specifically been working on a number of solutions in recent months, including a swab designed for COVID-19 test kits. Other projects include mask shields and adapters for converting snorkel masks to PPE.
The U.S. Food and Drug Administration has awarded Formlabs an emergency use authorization (EUA) for a 3D-printed part designed to convert BiPAP machines designed for sleep apnea into much-needed ventilators. The offering was one of dozens of ventilators and accessories granted such authorization over the weekend. The company plans to devote…
