Shenzhen-made oxygenation device gets nod for US sale

A disposable membrane oxygenator developed in Shenzhen has received market approval from the U.S. Food and Drug Administration (FDA) on Monday local time.

The Lifemotion ECMO system and its core disposable membrane oxygenator, developed by Chinabridge (Shenzhen) Medical Technology Co., have received U.S. FDA market approval. Courtesy of Chinabridge (Shenzhen)

Extracorporeal membrane oxygenation, or ECMO, is an external life-support system that can temporarily replace the heart and lungs functions of a patient with severe cardiac and pulmonary conditions.

It buys valuable time for treatment and allows the body's organs to recover. ECMO is often referred to as an “artificial heart-lung machine” and the disposable membrane oxygenator is a core component of the system.

The Shenzhen-made disposable membrane oxygenator approved for sale in the United States was independently designed and developed by Chinabridge (Shenzhen) Medical Technology Co., which is headquartered in Bao’an District.

The product was approved for clinical use in China in 2023, breaking the long-standing monopoly of U.S. and European manufacturers in the domestic market. Last year, it also received certification from TÜV SÜD, a German third-party testing and certification agency.

According to Chinabridge, the product has now gained market access in more than 40 countries and regions worldwide.