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Domestically Developed "Boron Neutron Capture Therapy System" Enters the National Special Review Procedure for Innovative Medical Devices

Recently, the Medical Device Technical Review Center of the National Medical Products Administration issued a public notice on the review results of applications for the Special Review Procedure for Innovative Medical Devices (No. 14 of 2026). The boron neutron capture therapy system independently developed by Huapeng Neutron Technology (Hangzhou) Co., Ltd. has officially entered the National Special Review Procedure for Innovative Medical Devices after the public notice period. Screenshot from the official website of the Medical Device Technical Review Center of the National Medical Products Administration. The Special Review Procedure for Innovative Medical Devices is a review channel established by the National Medical Products Administration to encourage medical device innovation and promote the application of new technologies, effective since December 1, 2018. According to the relevant procedures, drug regulatory authorities and technical institutions will, on the premise of not lowering standards and not reducing procedures,...

2026-09-10

Huzhou, Zhejiang Launches Phase I "Drug-Device Combination" Clinical Trial for the Province's First BNCT System

Recently, the Boron Neutron Tumor Treatment Center at Huzhou Hospital Affiliated to Zhejiang University School of Medicine has drawn attention with the introduction of the province's first Boron Neutron Capture Therapy (BNCT) system. Previously, the system had already initiated a Phase I BNCT drug-device combination clinical trial. According to the system developer, Huapeng Neutron Technology (Hangzhou) Co., Ltd., BNCT is a radiotherapy technique combining drugs and devices, with its core lying in the coordinated use of boron-containing drugs and neutron irradiation. After entering the human body, the boron-containing drug can be absorbed by tumor cells; subsequent neutron beam irradiation triggers a localized reaction to achieve targeted radiotherapy against tumor cells. Unlike conventional radiotherapy, which typically employs fractionated irradiation over a longer treatment course, BNCT emphasizes selective targeting of tumor cells, aiming to reduce damage to surrounding healthy tissues and lower radiotherapy-related side effects such as hair loss and immunosuppression.

2026-08-27

Anhui Juhe Haizhi Settles in Hefei, to Release Radiation-Related Maintenance Robots

Anhui Juhe Haizhi Technology Co., Ltd., jointly established by Jianghuai Laboratory, the Institute of Energy at Hefei Comprehensive National Science Center, Keda Silicon Valley, and Anhui Penggong Intelligent Equipment Technology Co., Ltd., has officially settled in Hefei. The company focuses on the industrialization of embodied intelligent equipment for extreme environments, with key deployments in high-risk operational scenarios such as nuclear radiation, deep sea, and specialty chemicals. Juhe Haizhi plans to release two embodied intelligent robots for extreme environments by the end of August 2026. Among them, the commercial fusion radiation-resistant maintenance robot is one of the key products to be released, providing unmanned intelligent maintenance solutions for nuclear radiation-related scenarios, with neutron target maintenance for Boron Neutron Capture Therapy (BNCT) devices being one of its core application scenarios...

2026-08-13

China's First Qualification for Radiation Health Testing and Evaluation of BNCT Equipment Approved

Recently, the Beijing Municipal Health Commission, in accordance with the "Administrative Measures for Radiation Health Technical Service Institutions" (Guoweiban ZhiJian Fa [2026] No. 1), organized experts to conduct on-site reviews of two qualification expansion applications submitted by the National Center for Occupational Safety and Health under the National Health Commission. The projects include performance testing and evaluation of Boron Neutron Capture Therapy (BNCT) equipment and thyroid iodine-131 testing. During the review process, the expert panel conducted a comprehensive examination of the center's management system, personnel allocation, instruments and equipment, and technical capabilities related to radiation health testing and evaluation through document review, technical inquiries, on-site practical operations, and simulated demonstrations...

2026-08-12

Fujita Health University in Japan Advances Research on Expanding BNCT Indications for Deep-Seated Cancers, to Conduct 18F-FBPA PET Exploratory Evaluation

On August 10, Stella Pharma Corporation of Japan announced that it is collaborating with Fujita Health University and other institutions to advance research and development aimed at expanding Boron Neutron Capture Therapy (BNCT) to deep-seated cancers. As part of this project, Stella Pharma will participate in an exploratory study on 18F-FBPA uptake capacity in deep-seated cancers conducted by Fujita Health University. The study will use 18F-FBPA PET to evaluate the tumor accumulation of boron drugs used in BNCT in deep-seated cancers, and based on the findings, explore the possibility of expanding BNCT indications in the future. The study plans to collect data from 50 cases, including pancreatic cancer, hepatocellular carcinoma, and biliary tract cancer, to accumulate foundational evidence needed for the development of BNCT for deep-seated cancers. BNC...

2026-08-11