ITRI announces FDA approval of locally made ventilator

Researchers at the Industrial Technology Research Institute (ITRI) with the ventilator (Courtesy of the ITRI)

TAIPEI (CNA) – The Industrial Technology Research Institute (ITRI) has received approval from Taiwan’s Food and Drug Administration (FDA) to manufacture and sell a ventilator it developed, the ITRI said in a press release Thursday.

The ventilator received Emergency Use Authorization (EUA) from the FDA on Aug. 12 and can be used to aid patients with respiratory failure, said Lin Chii-wann (林啟萬), director of ITRI’s Biomedical Technology and Device Research Laboratories.

The institute plans to make 10 FDA-approved ventilators during a trial production period before November, and is currently recruiting manufacturers to scale up production, with the goal of producing 100 ventilators by the end of June 2021.

The ITRI began working on the ventilator in late March, when United States ventilator manufacturer Medtronic publicly shared the design specifications of the company’s PB 560 portable ventilator, to accelerate ventilator production amid the COVID-19 pandemic, according to the ITRI.

After seeing the design, it took the institute only 17 days to source the more than 500 components needed to build a prototype, it said.