Shulou(Shulou.com)11/24 Report--

CTOnews.com January 5 news, the State Drug Administration website today announced "China's domestic extracorporeal membrane oxygenation (ECMO) products approved for marketing" information.

According to the website of the State Drug Administration, according to the needs of epidemic prevention and control work, in order to ensure the treatment needs of severe patients with new coronavirus pneumonia, on January 4,2023, the State Drug Administration approved the application for registration of extracorporeal cardiopulmonary support auxiliary equipment and disposable membrane oxygenator package of Shenzhen Hannuo Medical Technology Co., Ltd. after examination and emergency approval. The two are used together for acute respiratory failure or acute cardiopulmonary failure. Adult patients who are difficult to control with other treatments and have a foreseeable risk of continued deterioration or death. As the first ECMO equipment and consumables package made in China, the above products have independent intellectual property rights, and their performance indicators basically reach the international level of similar products.

CTOnews.com understands that extracorporeal cardiopulmonary support aids consist of a mainframe, pump drive unit, emergency pump drive unit, backup battery, flow bubble sensor, etc. Disposable membrane oxygenator kit consists of membrane oxygenator and arteriovenous tubing assembly (including centrifugal pump head), priming tubing assembly, accessory kit assembly and oxygen tubing.

ECMO products, as rescue treatment equipment for critically ill patients with new coronavirus pneumonia ineffective to conventional treatment, are clear treatment measures in the Diagnosis and Treatment Scheme for New Coronavirus Pneumonia. The marketing of domestic products will play an important role in meeting clinical urgent needs, ensuring the treatment of severe patients with new crown epidemic situation and ensuring the implementation of the goal of "health protection and severe disease prevention" for epidemic prevention and control.

In the process of registration application of this product, the State Food and Drug Administration established an emergency review working group in accordance with the principle of "unified command, early intervention, rapid and efficient, scientific approval," assigned personnel to be responsible for the whole process guidance, issued technical review guidelines, strengthened product registration application guidance, accelerated the review and approval process, promoted the listing of products as soon as possible on the basis of ensuring safety and effectiveness, and met the urgent needs of epidemic prevention and control work.

The drug regulatory authorities will strengthen the post-marketing supervision of this product to protect the safety of patient devices.

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