Source: Economic Daily News (Taiwan)

 Heron Neutron Medical Corp. Submits Medical Device Registration for “Bennu” AB-BNCT Neutron Irradiation System to Singapore HSA

  

Heron Neutron Medical Corp. today announced that it has officially submitted the medical device registration application for its self-developed “Bennu” Neutron Irradiation System to the Health Sciences Authority (HSA) of Singapore. This marks a significant milestone in advancing the deployment of Heron’s AB-BNCT system in Singapore and signifies that the development of the first AB-BNCT system in Southeast Asia has formally entered the regulatory review and substantive implementation stage.

 The submission of this product registration application is not only an important milestone in Heron’s international expansion, but also a strategic initiative to position Singapore as a regional hub for medical innovation in Southeast Asia, integrating healthcare, clinical research, and translational science resources. Heron will collaborate with the medical ecosystem of the National University of Singapore, including the National University of Singapore, the National University Hospital, and related clinical research institutions, as well as research organizations under Singapore’s Agency for Science, Technology and Research (A*STAR), to advance clinical research, drug development, treatment workflow optimization, and translational medical applications of AB-BNCT technology in the region.

 Mr. Leo Shen, General Manager of Heron Neutron Medical Corp., stated that Singapore possesses a well-established regulatory framework, an internationally oriented clinical research environment, and a highly mature biomedical innovation ecosystem, making it a key strategic location for introducing advanced cancer treatment technologies into Southeast Asia. The submission of the HSA medical device registration application indicates that Heron’s AB-BNCT system has entered a substantive phase in regulatory preparation, including technical documentation, quality management, and safety data readiness. The company will continue to support the review process by providing additional technical, safety, and clinical usage data as required by the regulatory authority, and will work closely with partners to advance system installation, clinical study design, and subsequent implementation planning.

 Heron Neutron Medical Corp. is committed to developing a comprehensive AB-BNCT solution, encompassing neutron irradiation systems, treatment planning systems, boron-based drug development, imaging guidance, and clinical implementation support. Going forward, the company will build upon its experience in Taiwan and leverage Singapore’s international medical and research platform advantages to advance the deployment and clinical development of AB-BNCT in Southeast Asia. The company will also strictly comply with regulatory requirements from Singapore authorities and provide timely updates in accordance with project progress. 

Heron Neutron Medical Corp. Submits Medical Device Registration for “Bennu” AB-BNCT Neutron Irradiation System to Singapore HSA