ZAP Surgical Receives Approval for ZAP-X® Gyroscopic Radiosurgery® Platform
Thursday, June 29, 2023
ZAP Surgical Systems announced that it has received National Medical Products Administration (NMPA) approval in China for its ZAP-X® Gyroscopic Radiosurgery® platform.
The ZAP-X system is an innovative medical technology that employs a groundbreaking design featuring gyroscopic mobility. This unique feature enables the system to direct radiosurgical beams from numerous angles, allowing for precise concentration of radiation on the tumour target. The primary goal of this pioneering approach is to safeguard healthy brain tissue and preserve patients' cognitive function.
ZAP-X known for being vault-free and cobalt-free, which sets it apart from traditional radiation treatment methods eliminates the need for building expensive shielded radiation treatment rooms and removes the requirement for maintaining, securing, and replacing live radioactive isotopes used in radiation beam production.
ZAP-X was previously granted the NMPA's China Medical Device Evaluation (CMDE) Green pathway, a fast track for research and approval of innovative medical devices. As part of the priority review, the completion of the pre-approval clinical study at PLAGH 301 confirmed the overall safety of patients and the treatment efficacy of ZAP-X.