Fish Leap Medical Noninvasive Respirator Sedion Approved by FDA

On April 1, Fish Leap Medical announced that it had received notice from the U.S. Food and Drug Administration (FDA) that its noninvasive ventilator products, owned by Suzhou Fish Leap Medical Technology Co., Ltd., had been granted an emergency use authorization (EUA) issued by the FDA.

Fish Leap Medical Noninvasive Respirator Sedion Approved by FDA

According to the announcement, Fish Leap Medical’s above-mentioned products this time signed the FDA’s EUA, is used during the outbreak for clinical treatment of patients temporary emergency authorization, if after the termination of the emergency, the company still wants to sell the product in the U.S. market, need to complete the corresponding FDA registration work already in progress. It is reported that Fish Leap Medical Non-Invasive Ventilator Products have obtained the Medical Device Registration Certificate issued by China’s State Drug Administration and completed the EU CE certification.

Fish Leap Medical Secretary Chen Jian previously told the Beijing Business Daily reporter, so far, non-invasive ventilators are expected to be nearly 10,000 units of overseas shipments. In addition, Fish Leap Medical has confirmed that the production of foreign ventilator orders have been scheduled for mid-May.

Fish Leap Medical said in the announcement, the company has received a large number of overseas orders for ventilators, because of the more complex ventilator product technology, strict quality control requirements, upstream suppliers capacity climb ingress will take a certain time, it is expected that the respirator order queue will continue.

In fact, the outbreak, with the exception of China, the world is facing a shortage of ventilators. Typically, the global ventilator capacity center is in Europe, and now, as China’s outbreak improves and it returns to work first, many Chinese ventilator producers are stepping up their efforts to make up for global supply constraints. But most ventilator stakes believe that global shortages are a difficult problem to solve.

Many companies have even switched to ventilators. On March 31, Tesla CEO Elon Musk tweeted that the company had a U.S. Food and Drug Administration-certified ventilator that would be shipped free of charge to the hospital.

Ford motored March 30 that it would start producing ventilators in the week of April 20, with the goal of producing 50,000 units in 100 days and 30,000 a month thereafter; Gm posted a photo of its Kokomo plant in Indiana on March 29. Show the company has started production of ventilators. GM says it is aiming to produce 10,000 ventilators a month by the summer, a production plan that only guarantees costs and is not profitable. In addition to Tesla, Ford and General Motors, more than a half 12 multinational automakers in the U.S. have begun preparations and production of ventilator equipment.

With the price of ventilators, which cost tens of thousands of dollars, rising, the governor of New York this week complained that the price of ventilators is now 1.5 times higher than when they first tried to buy them.