UltraGreen.ai Limited, a global leader in fluorescence-guided surgery and digital health solutions, today announced that its IC-FlowTM Imaging System V2 has received regulatory approval across multiple South and Southeast Asian markets, bringing the system’s global regulatory footprint to 45 territories. This development supports the Company’s strategy to broaden access to its fluorescence imaging technologies in the Asia Pacific (APAC) region.
The approvals include registration with the Central Drugs Standard Control Organisation (CDSCO), Government of India for India, approval by the Thai Medical Device Control Division for Thailand, approval by the Centre for Device Regulation, Health and Research (CDRRHR) for the Philippines, and approval by the Directorate General of Drug Administration (DGDA) for Bangladesh. These regulatory clearances authorise UltraGreen to commercialise the IC-FlowTM Imaging System V2 in the respective countries in accordance with local regulatory requirements.
Quek Mei Ling, Chief Business Officer (APAC) of UltraGreen, commented, “South and Southeast Asia represent important and growing healthcare markets. These milestones strengthen our ability to build long-term partnerships, support clinical education initiatives, and advance responsible commercialisation in alignment with quality and compliance standards.”
The clearances build on the Company’s recent approvals for Verdye (Indocyanine Green, pharmaceutical product) in the Philippines and the IC-FlowTM Imaging System V2 in Malaysia. With these latest milestones, UltraGreen continues to reinforce its regulatory presence across multiple jurisdictions. The IC-FlowTM Imaging System V2 is also approved in Singapore and New Zealand within the APAC region, as well as in the United States and Europe, reflecting the Company’s broader global expansion strategy.
