ZAP Surgical Systems has secured approval from China’s National Medical Products Administration for its ZAP-X Gyroscopic Radiosurgery platform.
Earlier, the company secured Chinese Medical Device Evaluation Green Pathway approval from the regulator for the platform.
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A pre-approval clinical trial was completed at PLA General Hospital 301 in Beijing, as part of the priority review. The trial demonstrated ZAP-X’s treatment efficacy and overall patient safety.
Using gyroscopic mobility, the system directs radiosurgical beams from various unique angles to accurately concentrate radiation on the tumour target.
This approach enables the protection of healthy brain tissue and preserves patient cognitive function.
Furthermore, the vault-free and cobalt-free system helps eliminate the construction of expensive shielded radiation treatment rooms.
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By GlobalDataIt also helps avoid maintaining, securing and regularly replacing live radioactive isotopes for radiation beam production.
ZAP Surgical Systems CEO and founder Dr John Adler said: “Following an intensive, multi-year effort we’re incredibly excited that the ZAP-X has finally received its regulatory approval in China.
“In time, China will become ZAP’s largest single market, which will benefit millions of Chinese brain cancer patients.”
In April this year, ZAP Surgical received a No Objection Certificate from the Atomic Energy Regulatory Board in India for this radiosurgery platform.
The approval allows the expansion of access to completely non-invasive treatment of brain tumours in the country.
