Recently, the plasma skin treatment device developed by Hefei CAS Ion Medical and Technical Devices Co., Ltd. (HFCIM) officially entered the National Medical Products Administration's "Special Review Procedure for Innovative Medical Devices" (NMPA Innovation Channel). This product is the first Class III active medical device in Anhui Province to enter the "NMPA Innovation Channel," pioneering an efficient and novel method for skin wound treatment.

Relying on two platforms, the China-Russia Superconducting Proton "Belt and Road" Joint Laboratory and the Plasma Application Joint Laboratory, HFCIM is using the scientific achievements of Hefei superconducting proton system to "lay eggs along the way." They are conducting research and development for the plasma skin treatment device and promoting its clinical application.

The plasma skin treatment device has successfully passed through multiple key stages, including development, testing, optimization of core components, testing against new standards, and clinical trials. It smoothly passed the special review for innovative medical devices, which is a full recognition and affirmation of the innovation and R&D capabilities of HFCIM. It also accumulates valuable experience for the NMPA registration of domestic superconducting proton radiotherapy systems, holding significant importance in promoting the industrialization of the company's high-end medical devices. HFCIM will stay true to its original mission, focus on clinical and patient needs, and continue to contribute to the health industry in China.

Closing Statement:

The plasma skin treatment device utilizes low-temperature plasma to effectively deactivate bacteria and other pathogenic microorganisms, promoting cell proliferation and blood vessel formation. It offers a novel clinical treatment solution for chronically non-healing wounds and fungal skin diseases. The product has undergone clinical trials in more than five domestic medical institutions, with results indicating significant advantages in accelerating wound healing and reducing the course of illness. It can be widely used in the treatment of various difficult-to-heal wounds and skin diseases in dermatology.

The NMPA (National Medical Products Administration) has established the "Special Review Procedure for Innovative Medical Devices" with the aim of encouraging research and innovation in medical devices, as well as promoting the dissemination and application of new technologies in the medical device field. The key evaluation criteria include clinical application value, innovative features, core patents, product finalization, among others. Entering the "NMPA Innovation Channel" implies that the product will receive early intervention, dedicated personnel, and comprehensive guidance. It will undergo a prioritized approval process without compromising standards or reducing procedures.