On September 29, 2021, according to the official website of the State Drug Administration, China’s first domestically developed "hydrodynamic therapy equipment" and "disposable debridement water-powered knife head" (hereinafter referred to as "CareSYS-jet water knife") won Batch listing.
"CareSYS-jet water knife" was developed by the technical team of China's local enterprise Hydro CareSYS Medical Co., Ltd. (hereinafter referred to as "Hydro CareSYS), using a new generation of digital technology, debridement is safer and more thorough, and the rehabilitation effect is better. "CareSYS-jet water knife" adopts patented technology with independent intellectual property rights, and its products are in an international leading position in a number of key indicators such as variable shear force amplitude and pressure control accuracy.
The first domestic scalpel approved for the registration certificate of innovative medical devices
Since the implementation of the special approval procedure for innovative medical devices on March 1, 2014, as of the end of September 2021, a total of 123 medical device products in China have been approved for innovative medical device registration certificates, of which 2 items have been approved for innovative medical devices related to scalpels , Respectively, are a single-use debridement hydrodynamic cutter head and hydrodynamic treatment equipment. This progress is an important milestone in the transformation of the technology of the transformation center to clinical, and it indicates that the latest achievements of Hydrocosa in medical waterjet will enter the fast lane of clinical transformation.
The first domestic medical waterjet technology is at the international leading level
Hydro CareSYS is a national high-tech enterprise integrating R&D, production and sales of medical devices. The company has rich experience in multiple core technologies such as precision mechanical engineering, fluid mechanics, high-performance materials, automatic control, electronic circuits, software, and biomedical evaluation. At present, it has mastered miniature aseptic high-pressure technology, helium sealing technology, and Core technologies such as new organization-specific algorithms for deep learning.
The special approval procedure for innovative medical devices is very strict for the approval conditions for the products applied by enterprises. It emphasizes that the main working principle and mechanism of the product must be domestically pioneered. The product performance or safety is fundamentally improved compared with similar products, and the technology is in the international market. Leading level, and has significant clinical application value. The "CareSYS-jet water knife" was developed by the Hydrocosai team after 8 years of painstaking research. The "CareSYS-jet water knife" uses the tissue separation effect of high-pressure and high-speed water jets and the Venturi effect (a vacuum effect is formed near the high-speed water flow, which will remove The inactivated tissue fragments, wound secretions, bacteria and their biofilms will be absorbed and taken away together with the water flow) to remove necrotic and infected tissue; excision, washing and recovery are three in one, completed simultaneously.
The approval of the "CareSYS-jet water knife" registration certificate for innovative medical devices is not only the leading force in China's independent innovation of medical devices, but also reflects China's medical device innovation capabilities. The medical waterjet industry will usher in a major revolution in the future!
