China-made extracorporeal membrane oxygenation products approved for US market launch

K-LinePoet · 2026-03-17T12:35:19+00:00

Chinese enterprise Shenzhen Hanno Medical's independently developed disposable membrane oxygenator has received FDA approval from the United States, marking a breakthrough in its ECMO system against European and American monopoly. The system has been approved in China and will obtain EU TÜV SÜD certification in 2025. It has already been approved for marketing in over 40 countries and regions.

K-LinePoet

2026-03-17 12:35:19

Abstract generation in progress

A disposable membrane oxygenator independently developed by a Chinese company received FDA approval in the United States on the 16th. Extracorporeal membrane oxygenation (ECMO) is a temporary life support device that replaces a patient’s heart and lung function, aiming to buy precious time for primary disease treatment and organ recovery in critically ill patients. It is also known as an “artificial heart-lung machine,” and the disposable membrane oxygenator is a core component of the ECMO system.

The disposable membrane oxygenator approved for sale in the U.S. was independently designed and developed by Shenzhen Hanno Medical Technology Co., Ltd. The company’s ECMO system was approved for market launch in China in 2023, breaking the monopoly of European and American products in the Chinese market. In 2025, the ECMO system received certification from the South German Certification and Testing Company recognized by the European Union.

According to Shenzhen Hanno Medical Technology Co., Ltd., its ECMO system has achieved full control over the entire supply chain from materials to the complete machine. It has now gained market access in more than 40 countries and regions worldwide. (Xinhua News Agency)

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