US-based Zap Surgical Systems Inc. has announced that it has received market approval in China for its innovative ZAP-X Gyroscopic Radiosurgery Platform. This advanced system is designed for the treatment of brain tumors, lesions, and other head and neck conditions. The ZAP-X system utilizes unique gyroscopic mobility to direct radiosurgical beams from numerous angles, ensuring precise concentration of radiation on the tumor target while significantly reducing radiation leakage and scatter. This technology minimizes the impact on off-target healthy tissue during treatments.
NMPA’s Green Pathway Status and Clinical Trial Data
According to the press release, the National Medical Products Administration (NMPA) has granted green pathway status to the ZAP-X platform, signifying a faster approval process. The approval filing was supported by data from a pre-approval trial conducted at the PLA General Hospital 301 in Beijing, which demonstrated the safety and efficacy of the ZAP-X system in treating neurological conditions.
Zap Surgical Systems’ Future Outlook in China
Zap Surgical Systems Inc. is optimistic about its future in the Chinese market, anticipating that China will eventually become the largest market globally for treatments using its ZAP-X platform. The company’s receipt of NMPA approval is a significant step towards expanding its global footprint and improving access to advanced radiosurgery for patients in China.-Fineline Info & Tech
