HERON TECHNOLOGY Announces Application for Medical Device Product Registration of “Benu” Neutron Radiation System with Singapore’s Health Sciences Authority (HSA)
HERON TECHNOLOGY has submitted an application to the Singapore Health Sciences Authority (HSA) for the medical device product registration of its “Benu” Neutron Radiation System. The company has authorized its Singapore subsidiary, HERON NEUTRON MEDICAL SINGAPORE PTE. LTD., to act as the local registrant, handling all regulatory processes. The “Benu” Neutron Radiation System utilizes Boron Neutron Capture Therapy (BNCT), an advanced radiation therapy that precisely targets and destroys tumor cells with minimal harm to healthy tissues, offering a promising treatment for cancers like recurrent head and neck cancer and glioblastoma.
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- 📰 Published: May 6, 2026 at 09:00
- 🔍 Collected: May 7, 2026 at 08:00 (23h 0m after Published)
- 🤖 AI Analyzed: May 7, 2026 at 09:01 (1h 1m after Collected)
1. Date of occurrence of the event: 2026/05/06
2. Company name: HERON TECHNOLOGY CO., LTD.
3. Relationship with the company (please enter “the company” or “subsidiary”): The company
4. Mutual shareholding ratio: Not applicable
5. Reason for occurrence: The company has completed the submission of its application for medical device product registration of the “Benu” Neutron Radiation System to the Health Sciences Authority (HSA) of Singapore.
6. Countermeasures: In response to the regulatory requirements of the Singapore medical device authorities, the company, as the product manufacturer and product owner, has authorized its Singapore subsidiary, HERON NEUTRON MEDICAL SINGAPORE PTE. LTD., to act as the Singapore product registration holder (Registrant). The subsidiary will be responsible for handling medical device product registration, maintenance of product registration, annual retention, notification of changes, and related follow-up operations with the Health Sciences Authority (HSA) of Singapore. The company will provide complete technical documents, quality system data, and post-market surveillance support. The subsidiary will coordinate local regulatory communication, application submission, and supplementary document response processes to ensure the completeness of application data, compliance with registration conditions, and maintenance of product supply compliance in the Singapore market.
7. Other matters that need to be specified (If the subject of the event or resolution is a public company or above, this material information also complies with Article 7, Paragraph 9 of the Enforcement Rules of the Securities and Exchange Act, which stipulates matters that have a significant impact on shareholders'' equity or securities prices): Boron Neutron Capture Therapy (BNCT) system is an advanced radiation therapy technology that combines nuclear physics and precision medicine. Its principle is to first selectively gather boron-containing drugs in tumor cells, and then irradiate them with low-energy neutrons, causing boron atoms to undergo nuclear reactions and release high-energy particles. This precisely destroys tumor cells at the cellular level while minimizing damage to surrounding normal tissues. BNCT is particularly suitable for recurrent head and neck cancers, malignant brain tumors (such as glioblastoma), and other tumors where traditional radiotherapy has limited effects or surgical removal is difficult. Its advantages include high selectivity, achieving therapeutic effects with a single or few treatments, and the potential to reduce side effects and improve quality of life.
2. Company name: HERON TECHNOLOGY CO., LTD.
3. Relationship with the company (please enter “the company” or “subsidiary”): The company
4. Mutual shareholding ratio: Not applicable
5. Reason for occurrence: The company has completed the submission of its application for medical device product registration of the “Benu” Neutron Radiation System to the Health Sciences Authority (HSA) of Singapore.
6. Countermeasures: In response to the regulatory requirements of the Singapore medical device authorities, the company, as the product manufacturer and product owner, has authorized its Singapore subsidiary, HERON NEUTRON MEDICAL SINGAPORE PTE. LTD., to act as the Singapore product registration holder (Registrant). The subsidiary will be responsible for handling medical device product registration, maintenance of product registration, annual retention, notification of changes, and related follow-up operations with the Health Sciences Authority (HSA) of Singapore. The company will provide complete technical documents, quality system data, and post-market surveillance support. The subsidiary will coordinate local regulatory communication, application submission, and supplementary document response processes to ensure the completeness of application data, compliance with registration conditions, and maintenance of product supply compliance in the Singapore market.
7. Other matters that need to be specified (If the subject of the event or resolution is a public company or above, this material information also complies with Article 7, Paragraph 9 of the Enforcement Rules of the Securities and Exchange Act, which stipulates matters that have a significant impact on shareholders'' equity or securities prices): Boron Neutron Capture Therapy (BNCT) system is an advanced radiation therapy technology that combines nuclear physics and precision medicine. Its principle is to first selectively gather boron-containing drugs in tumor cells, and then irradiate them with low-energy neutrons, causing boron atoms to undergo nuclear reactions and release high-energy particles. This precisely destroys tumor cells at the cellular level while minimizing damage to surrounding normal tissues. BNCT is particularly suitable for recurrent head and neck cancers, malignant brain tumors (such as glioblastoma), and other tumors where traditional radiotherapy has limited effects or surgical removal is difficult. Its advantages include high selectivity, achieving therapeutic effects with a single or few treatments, and the potential to reduce side effects and improve quality of life.