[Scivita Medical] “Intelligent Manufacturing in China”: Highlight of Innovation Scivita Medical 4K Ultra HD Endoscope becomes the first FDA certified product in China

The 4K INSIGHT series 4K Ultra HD endoscopy camera system made by Scivita Medical has passed the extremely strict audit of the US FDA and becomes the first FDA approved 4D Ultra HD endoscopy made in China. The FDA audit certificate was granted on August 24, 2020. This is another milestone Scivita Medical obtained after its 4D Ultra HD endoscopy obtaining NMPA approval in 2019. The successful clearance represented the starting point of the road for Chinese-made endoscope to the highest-end international competition in the industry. This may bring about huge changes to the competitive landscape of the international endoscope market. For China's high-end endoscope industry, Scivita Medical is the first to participate in global market competition.

The 4K INSIGHT series of endoscope products that have obtained FDA certification this time are independently developed by Scivita Medical are powered by a number of independent intellectual property rights and invention patents at home and abroad. The optical-level hard mirror, camera, camera host, signal transmission and medical monitor of this series all reached medical 4K standards, ensuring that doctors are provided with medical-grade 4K image quality with international advanced level. In order to solve clinical pain points, this series of products are also designed with special functions such as smoke removal, blood vessel enhancement, wide dynamic imaging, dark area enhancement, exposure correction, special light, etc. Scivita Medical’s unique smoke removal and blood vessel enhancement functions have been recognized and praised by many domestic and foreign clinical experts. Trial reports conducted by multiple departments in more than 300 Grade-A Tertiary hospitals in China achieved highly rated feedback that Scivita Medical’s product is “comparable to imported top brand products”. From now on, the idea that "domestic equipment are inferior to imported ones" needs to be changed. The endoscope industry has the lowest domestic production rate (about 5%) among all medical devices. The leading quality of Scivita Medical’s product has reached or exceeded that of the imported brands, fully satisfying the clinical needs. Therefore, it is expected to Scivita Medical will drive the trend of replacing imports with Chinese products in the endoscope industry.

Scivita Medical Technology Co., Ltd. was established in Suzhou Industrial Park in 2016. It is a high-tech enterprise with optical diagnosis and treatment, multi-dimensional imaging, high-performance materials and precision manufacturing as the starting point of scientific and technological innovation. The company owns independent intellectual property rights and independent brand products, and is engaged in research and development, production and operation in the field of minimally invasive diagnosis and treatment. Several doctors who studied overseas and returned China joint the founding team. They have years of experience in high-tech exploration and product development in the world's top medical device companies. The team also has accumulated a wealth of entrepreneurial experience in China. Based in China, Scivita Medical has not only maintained close cooperative relations with domestic experts, but also cooperated with relevant universities and enterprises in Europe, America and Japan. Combined with the technological and production advantages of countries, minimally invasive medical instruments featured by high efficiency and safety are developed and produced for clinical use. Since its establishment, the company has set up a first-class R&D center in Japan, and through the acquisition of Japanese professional companies, it is ahead of many competitors in the research and development of image processing and the innovation of endoscope technology. Its team members come from many world-renowned companies, specializing in the research and development of related technologies and clinical practice for many years, with rich experience and cutting-edge vision. There are many world-leading scientific and technological products in Scivita Medical product lines, especially the new-concept endoscope and its imaging system are recognized as the most outstanding innovative products with breakthrough influence. This will greatly improve and meet the increasing clinical requirements for surgical schemes and innovative treatment methods. Soon after, Scivita Medical will launch a series of disposable endoscope products covering multiple departments and leading technology, 3D, 4K, fluorescent endoscope camera system, intelligent endoscope system based on AI and other new products facing the global market, which can be expected in the future!

Scivita Medical Technology Co., Ltd. has been adhering to the company tenet of "innovation, optical technology, and multi-dimensional development", and is committed to providing global clinical experts with endoscopic camera products "intelligent manufacturing in China, innovative, with high-quality, and affordable". FDA clearance of its product represented that endoscopy made in China official launched in the global market. Scivita Medical shoulders the responsibility of supporting China’s development with “made-in-China” product. The very first FDA clearance of its 4K INSIGHT series laid the first milestone of the strategy of China's high-end endoscope industry in the global market. It’s a starting point of a new journey. Starting with the 4K INSIGHT series, Scivita Medical is willing to provide more high-quality medical imaging products to more counties and regions around the word, so that medical experts around the world benefit more patients using high-quality medical imaging products made in China.