Heron Technology''s Neutron Radiation System Applies for Singapore Medical Device Registration
Heron Technology has announced the completion of its application for medical device product registration of its ''Benu Neutron Radiation System'' with the Singapore Health Sciences Authority (HSA). This marks a significant step for the company''s product entry into the Singapore market.
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- 📰 Published: May 6, 2026 at 16:39
- 🔍 Collected: May 6, 2026 at 17:01 (22 min after Published)
- 🤖 AI Analyzed: May 6, 2026 at 17:04 (2 min after Collected)
Heron Technology announced today that it has completed the submission of its application for medical device product registration of the ''Benu Neutron Radiation System'' to the Singapore Health Sciences Authority (HSA). Heron Technology stated that it has authorized its Singapore subsidiary, HERON NEUTRON MEDICAL SINGAPORE PTE. LTD., to serve as the Singapore Product Registrant. This subsidiary will be responsible for handling medical device product registration, maintaining registration, annual retention, notifying changes, and other related follow-up operations with the HSA. Heron Technology will provide comprehensive technical documentation, quality system data, and post-market surveillance support. The subsidiary will coordinate local regulatory communication, application submission, and responses to requests for supplementary documents to ensure the application materials are complete, meet registration requirements, and maintain product compliance for supply in the Singapore market. Heron Technology explained that the Boron Neutron Capture Therapy (BNCT) system is an advanced radiotherapy technology that combines nuclear physics with precision medicine, particularly suitable for recurrent head and neck cancer, malignant brain tumors, and similar conditions.