First domestic self-developed iAED-S1 gets approval to enter market
Recently, the semi-automatic defibrillator (iAED-S1), developed by Jousing Medical Technology (Suzhou) Co., Ltd (Jousing Medical) received the CFDA approval on Class III medical device, becoming the first domestically approved automatic external defibrillator (AED), ideal for use by ordinary people. It bridges the AED gap in China and breaks stranglehold of foreign brands.
▲CFDA official website (http://samr.cfda.gov.cn) announces the approval of iAED-S1.
▲Search result of external defibrillator in the CFDA official website (http://samr.cfda.gov.cn)before May 15
The AED is a portable and easy first-aid medical device. It can skillfully be used after a brief training session. Notably, the AED can offer timely and effective defibrillation after instinctively identifying and analyzing some of the most common symptoms of sudden cardiac arrest (SCA), and a trained eyewitness can use it to save patients in an emergency situation.
What is SCA?
SCA refers to abnormal heart pulsations caused by a variety of reasons, resulting to interruption of blood perfusion as well as severe anoxia and ischemia in the whole body; symptoms include sudden syncope (without signs)，unconsciousness，cessation of breathing, or no pulse. Inability to get immediate help could result to death. This is referred to as sudden cardiac death (SCD).
According to statistics, if cardiac arrest stretches for more than 5 minutes, it could result to serious brain damage or death. There is an increase in the number of deaths caused by cardiac arrest compared to cancer and traffic accidents.
The electrical defibrillation offers a solution to normalize heart rhythm, supporting rescuers, who are racing against time to save patients.
Sudden cardiac arrest can happen to anyone, anytime and anyplace.
At least 540,000 patients die from sudden cardiac death (SCD) in China every year, with 90% dying outside hospitals. Given that traditional medical aid system lacks timely and effective rescue strategy, the survival rate of out-of hospital patients with SCD is almost nil， making the death rates higher than other causes. The condition has become the second highest killer in China.
The AED buys patients with ventricular fibrillation valuable time to seek further treatment in hospital. Indeed the increased awareness of first aid and effective precaution have pushed up the rescue success rate of out-of hospital patients by nearly 40% in developed countries.
Domestically, research and development of AED started late, but Jousing Medical developed AED and gained CFDA approval after 5 years of unremitting efforts. “Previously, domestic AED products partially depended on imports. What we did was to break foreign monopoly and develop our own product to avoid lagging behind other countries. In addition to competing with foreign products in performance, domestic AED product provides cost-effective and high-quality services to patients.” said Sun Jianyan, general manager of Jousing Medical who has full confidence of his team, product’s technology and market.
The iAED-S1 is the first domestic semi-automatic external defibrillator developed by Jousing Medical. In addition to compatibility and portability, the product provides clear phonetic instructions and various light indicators to help users complete every cardiopulmonary resuscitation and defibrillation step.. The product adopts unique low-energy biphasic wave and dynamic impedance compensation technologies to ensure higher success rate of defibrillation. Besides boosting survival rates, it minimizes the side effect of myocardial damage caused by electric shock.
About Jousing Medical Technology (Suzhou) Co., Ltd
Suzhou Jousing Medical Technology (Suzhou) Co., Ltd, located at BioBay, Suzhou, is a professional pre-hospital first-aid device and solution provider in the cardiovascular field. The company was founded by a group of people boasting of leading technology and rich operation experience in the industry. The company has netted dozens of invention patents and developed several products with complete independent intellectual property rights. The company has also attracted millions of funds from SIP Leading Talent Program and government.