First domestic ECMO approved for emergency use
China's drug regulator yesterday granted emergency use authorization to a domestically produced ECMO system that provides extracorporeal life support for critically ill patients.
It is expected to meet the demand for treating serious COVID patients, making it the first such domestic device to receive the go-ahead.
Shenzhen-based Chinabridge Medical manufactures Lifemotion, an extracorporeal membrane oxygenation (ECMO) system for severe acute respiratory failure, as well as its accompanying kit.
The National Medical Products Administration said on its website that the first ECMO equipment and supply kits developed in China have independent intellectual property rights and are on par with comparable foreign-produced products.
An ECMO device is a measure that is specified in China's treatment recommendations as a treatment device for critically sick patients with novel coronavirus pneumonia.
According to the statement, the introduction of the domestic product will be crucial in addressing urgent clinical demands.
To ensure the products are used safely, the administrator will enhance product oversight.