Another good news for Deep01! Taiwan`s first AI product obtained marketing approval from Japan`s FDA

DeepCT - Intracranial Hemorrhage (ICH) AI Detection Software - developed by Taiwan`s high-profile AI start-up team Deep01 - has obtained the marketing approval of Japan`s PMDA, which is the first deep learning software officially licensed by Japan in Taiwan , marking a new milestone in Taiwan`s AI medical output.

Japan has the world`s most aging population, and with advanced medical development, the average number of Computed Tomography (CT) scans per million people is more than 111, and the density is the highest in the world. Due to the large elderly population and the lack of radiologists, the introduction of advanced technology to assist in interpretation has become an inevitable trend at present and in the future. DeepCT uses exclusive deep learning technology to develop fast and accurate interpretation software, which can detect intracranial hemorrhage through computed tomography (CT) images, assisting radiologists and emergency physicians in the middle of the night or when manpower is insufficient, 30 seconds. The results of suspected bleeding can be used as an important reference for medical decision-making to improve efficiency and accuracy, so that patients can be treated faster.

Zhou Renhai, CEO of Deep01, said that in the field of AI medical care, Taiwan can make world-class products, and Deep01 is the best example. In the vertical field of brain CT imaging, Deep01 has achieved global leadership. The AI functions of Deep01 are more complete than those of overseas competitors, and the AI computing speed is nearly 10 times faster. In addition, in terms of systems, Deep01 has a complete solution for front-end PACS (medical image storage and transmission system), web page, App display, back-end cloud and ground. It is hoped that with such a good product, it will serve more brain-injured patients around the world, especially in places where medical resources are lacking.

Chen Yanyu, the executive partner of Bibi Biomedical Ventures, said that Deep01 is one of the teams with the fastest execution and international development among the new ventures invested by BIG Biomedical. In the process of Taiwan`s AI medical treatment entering the international market, it is extremely important to obtain local regulatory certification in other countries. Only with certification can it be legally marketed in various countries. The speed of Deep01`s evidence collection in various countries is not only the first in Taiwan, but also in the leading position in the Asia-Pacific region, which proves the strength of Taiwan`s AI medical innovation in the world, and it is the light of Taiwan.

DeepCT developed by Deep01 is the first deep learning product certified by the US FDA in the Asia-Pacific region, and also the first deep learning product certified by the Taiwan FDA, and has been successively certified by the European Union, Thailand, Hong Kong, Malaysia, Japan and other countries, and ISO13485. DeepCT has served more than 60,000 cases in Taiwan. This year, it has signed exclusive agents in more than 20 countries and is actively expanding into the world. Japan is the top two medical markets in the world, and stroke or cerebral hemorrhage due to falls commonly occurs in the elderly. Deep01`s fast and accurate AI system is expected to bring medical benefits to the aging Japanese society.