China's top drug regulator on Thursday granted emergency approval for the use of the first domestically developed extracorporeal membrane oxygenation machine to treat COVID-19 patients in critical condition.
ECMO is a complicated life support device often used as a last-ditch treatment method for patients exhibiting critical organ failure.
The homegrown equipment, made by Chinabridge Medical in Shenzhen, Guangdong province, is cleared for use among adult patients who have acute respiratory or cardiopulmonary failure and are at high risk of experiencing worsening conditions or death.
"The product's key performance indicators are on par with those of its international peer products," the National Medical Products Administration said in a statement.
"The newly issued approval will enable the product to play an important role in meeting clinical demands and guaranteeing treatment for seriously ill COVID-19 patients," it added.
Drug regulators will vigilantly monitor the equipment to ensure safety, the administration said.
By Dec 25, China had about 2,600 ECMO machines, according to the National Health Commission.
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