Taiwan’s First AI Medical Device Obtains Japanese FDA Approval

Article By : Deep01

DeepCT, an Intracranial Hemorrhage (ICH) AI detection software developed by Taiwan's highly anticipated AI startup company Deep01, obtained the medical device approval from Japan PMDA.

DeepCT, an Intracranial Hemorrhage (ICH) AI detection software developed by Taiwan’s highly anticipated AI startup company Deep01, obtained the medical device approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This is the first deep learning software in Taiwan that has been officially licensed by Japan, setting the new milestone for Taiwan’s AI medical device.

Japan is the most aging society in the world, with advanced medical development, it has the highest density of computed tomography (CT) per million people, more than 111. Due to the large number of elderly people and lack of radiologists, the introduction of advanced technology to assist interpretation of CT images has become an inevitable trend both at present and in the future. DeepCT uses exclusive deep learning algorithm to develop fast and accurate interpretation software that can detect intracranial hemorrhage through computer tomography (CT) images. Radiologists and emergency physicians can obtain the results of suspected ICH in 30 seconds as an important medical decision-making reference, improve efficiency and accuracy, and enable patients to be treated faster.

Deep01 CEO David Chou believed that in the medical AI field, Taiwan can make world-class products, and Deep01 is the best example. In the vertical market of brain CT imaging, Deep01 has become a global leader. Deep01’s AI functions are more versatile than those of competitors. AI calculation speed is nearly 10 times faster. AI accuracy has also been certified by many hospitals in the United States, Taiwan, and Hong Kong. In addition, in terms of systems, Deep01 has all solution for the front-end PACS (medical image storage and transmission system), web page, mobile application, cloud service, and the localization.

“We hope that with such a good product, it can serve more brain injury patients around the world, especially in places where medical resources are scarce,” said Chou.

“Among all of our invested ventures, Deep01 is one of the teams with the fastest execution and international development,” said Chen Yanyu, managing partner of BE Accelerator. In the process of Taiwan’s AI medical device company entering the international market, it is extremely important to obtain the regulatory certification of other countries. Only with certification can products be legally marketed and sold in various countries. The pace of Deep01 obtains certifications in various countries is not only the fastest in Taiwan, but also the leader in the Asia-Pacific region, showing the strength of Taiwan’s AI medical innovation to the world.

DeepCT, developed by Deep01, is the first deep learning medical device that obtained the U.S. FDA clearance in the Asia-Pacific region, and the first deep learning medical device approved by the Taiwan FDA. It also has successively obtained certifications from the European Union, Thailand, Hong Kong, and Malaysia, to name a few, along with the ISO 13485 certification. DeepCT has already served more than 60,000 cases in Taiwan. This year, it has signed exclusive agents in more than 20 countries worldwide and is actively continue to expand. Japan is the world’s top two medical markets, and strokes or cerebral hemorrhage caused by falls generally occur in the elderly. Deep01’s fast and accurate AI system is expected to bring medical benefits to the aging Japanese society.


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