Heavy news from the State Drug Administration! The first domestic medical waterjet independently researched and developed by Hydraulics has been approved for listing!
Today, the State Drug Administration came heavy news that the "hydrodynamic therapy equipment" and "disposable debridement water-powered cutter head" (hereinafter referred to as "CareSYS-jet water knife") pioneered by Hydro CareSYS were approved. Listed.
"CareSYS-jet water knife" was developed by the technical team of Shenzhen Hydrocosa 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; "Waterjet" adopts patented technology with independent intellectual property rights, and the product is in an international leading position in a number of key indicators such as variable shear force amplitude and pressure control accuracy.
The picture is a screenshot of the official website of the State Drug Administration
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 "disposable debridement hydrodynamic cutter head" and "hydrodynamic therapy 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 picture shows the product picture of "CareSYS-jet water knife"
The special approval procedures for innovative medical devices are very strict for the approval conditions for the products applied by enterprises. The emphasis is on the core patents and innovations of the products, and the core technology invention patents are required; at the same time, the product performance or safety is required to be fundamentally improved compared with similar products. , Technically at the international leading level, and has significant clinical application value. "CareSYS-jet water knife" is the result of more than 10 years of research and development by the Hydro CareSYS team. The approval of the "CareSYS-jet water knife" for innovative medical equipment is the result of the joint efforts of all Hydro people.
The advanced nature of "CareSYS-jet water knife" technology has been affirmed by government departments and experts
"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/air flow, which removes inactivated tissue fragments, wound secretions, bacteria and their biofilms, etc., together with the water flow Absorb and take away together) to remove necrotic and infected tissue; the trinity of excision, washing and recovery is completed simultaneously. As China's first self-developed medical waterjet, "CareSYS-jet water knife" fills the gap in China's medical waterjet industry. "CareSYS-jet water knife" was recognized as a "specialized and special new" product in 2020, selected as a national innovative medical device in 2020, and was approved as a major scientific and technological project of Guangdong Province in 2021. It has won the clinical value and technological innovation from national authoritative departments and medicine. Great affirmation from domain experts.
"CareSYS-jet water knife" has been approved for the three-category medical device registration certificate to legally and compliantly provide excellent clinical solutions to medical institutions across the country, and create good conditions for strengthening the precision treatment, comfort treatment, safe and efficient treatment of wounds. In the future, Hydrocosa will establish a new standard for medical waterjet treatment, helping China's wound treatment to advance to the world-class level!
