China NMPA Approves Innovative Head And Neck X-ray Stereotactic Radiosurgery System For Market

On June 20, 2023, NMPA approved for the registration application of the cutting-edge medical device, the “Head and Neck X-ray Stereotactic Radiosurgery System,” manufactured by ZAP Surgical Systems, Inc. BradyKnows provides the turnkey solution to this innovative device, covering registration, type testing, clinical trial, clinical evaluation, post market surveillance and other aspects of the whole life cycle.

The system is specifically tailored for the precise treatment of intracranial and cervical solid malignant tumors and lesions. One of the standout features of this product is its self-shielding structure, which effectively contains radiation levels within safe thresholds, thereby eliminating the need for the construction of protective walls. This innovative design not only ensures the safety of patients and healthcare professionals but also significantly reduces the costs associated with the construction of hospital rooms.

Furthermore, the inclusion of a tungsten collimator and an optimized linear accelerator enhances the accuracy of radiation dosage, minimizes radiation penumbra, and maximizes the concentration of radiation within the tumor area, while minimizing exposure to healthy surrounding tissues. These features provide a notable clinical advantage in the treatment of patients.

In light of the approval, the regulatory authority for medical products remains committed to robust post-market supervision of the “Head and Neck X-ray Stereotactic Radiosurgery System.” The goal is to ensure stringent safety standards are upheld, safeguarding patients during the device’s usage.

With the successful registration of this groundbreaking product, the medical community eagerly anticipates its implementation, as it promises to revolutionize the field of radiation therapy and improve patient outcomes in the treatment of intracranial and cervical solid malignant tumors and lesions.

BradyKnows is the most elite team on supporting the market entry of famous radiotherapy device manufacturers in the world, including Elekta, Varian, ZAP Surgical Systems, United Imaging etc. Our services covers from the pre-market R&D, registration, clinical trial to post-market compliance and sales. For any questions about China market, pls reach out to us via info@bradyknowsmedical.com.