Innovative Implantable Deep Brain Stimulation System and Proton Therapy System Receive NMPA Approval for Market Launch

(Source: China Food and Drug Administration Network)

China Food and Drug News (Reporter Luonan) On December 15, the National Medical Products Administration released information showing that the implantable deep brain stimulation system developed by SceneRay Co., Ltd. and the proton therapy system created by Varian Particle Therapy Co., Ltd. have been approved for marketing. Statistics show that so far this year, 73 productsInnovative HealthcareDevice Approved for Marketing.

NMPA Approves SceneRay Co., Ltd.'s Implantable Deep Brain Neurostimulator, Implantable Deep Brain Neurostimulation Electrode Leads, and Implantable Deep Brain Neurostimulation Extension Leads for Registration. The above products are used in combination to form the Implantable Deep Brain Neurostimulation System, which stimulates the nucleus accumbens and anterior limb of the internal capsule for relapse prevention as an adjunctive treatment in patients with refractory moderate to severe opioid addiction. The Implantable Deep Brain Neurostimulation System fills a technical gap in the physical intervention-based treatment of opioid addiction, offering more options for the treatment of patients with opioid dependence.

The proton therapy system of Varian Medical Systems Particle Therapy Co., Ltd. consists of an accelerator subsystem and a treatment subsystem. The accelerator subsystem includes the main accelerator system, energy selection system, and beam transport system, while the treatment subsystem includes a 360° rotating beam treatment system and treatment planning system. It is suitable for treating solid malignant tumors throughout the body and specific benign conditions. The product adopts a compact design with a cantilever gantry, which can save space for proton equipment and improve treatment efficiency.

The drug supervision and administration department will strengthen the post-marketing supervision of the aforementioned products to protect the safety of patients using medical devices.

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(Editor: Guo Xiao)