ZAP Surgical Systems has received a No Objection Certificate (NOC) from India’s Atomic Energy Regulatory Board (AERB) for its first ZAP-X Gyroscopic Radiosurgery platform.

According to the medical device company, the ZAP-X system has been developed exclusively for the treatment of brain tumours, lesions, and other conditions of the head and neck.

The system comes with vault-free SRS technology that eliminates the need for expensive shielded treatment bunkers and uses a modern linear accelerator to prevent the use of Cobalt-60.

It uses a tungsten-shielded circular collimation system to reduce the radiation leakage to less than 0.002% of the primary beam.

ZAP-X eliminates the need to host volatile live radioactive isotopes, to cut the impact of source decay, recurring replacement, regulatory licensing and source security.

Furthermore, its SRS-only design allows for a linac source-axis distance (SAD) of 45cm, reducing beam penumbra by about 50% compared to the 100cm SAD typical of full-body radiation platforms.

ZAP Surgical country head of India Saloni Singh said: “At ZAP, our mission is to expand world-class SRS access to the millions of potential patients who currently lack access throughout the world.

“By reducing the costs and complexities of prior delivery technologies, ZAP-X is enabling broader adoption of such technology and is primed to make a significant impact on patient care in India.”

Radiosurgery is a non-invasive alternative to surgery for the treatment of several brain tumours, including brain metastases and functional disease.

Unlike conventional surgery, radiosurgical procedures do not require any incision, don’t induce pain, and often allow patients to return to normal activities immediately.

With regulatory approval in India, the company is enabled to bring the benefits of SRS to a wider population of patients across the world.

The company has opened a new office in Gurgaon, India, to supervise the further market penetration and commercialisation of its radiosurgery system.

ZAP Surgical IMEA regional business director Ahmed Salem said: “By introducing leading-edge innovations such as self-shielding and a modern linear accelerator, ZAP-X has removed many of the financial and logistical constraints that previously prohibited centres from acquiring SRS technology.

“Where state-of-the-art SRS has historically been concentrated primarily amongst the most well-funded, urban academic hospitals, ZAP-X now makes SRS also feasible in suburban and rural settings – thus bringing potentially life-saving care to previously underserved populations.”