UltraGreen.ai gains regulatory nod in four countries, boosts global expansion

It will expand in India, Thailand, the Philippines, and Bangladesh.

UltraGreen.ai Limited received regulatory approval for its IC-Flow Imaging System V2 in India, Thailand, the Philippines, and Bangladesh, expanding its global footprint to 45 territories, according to a press release.

The approvals allow the company to commercialise the hand-held near-infrared fluorescence imaging platform in each country under local regulatory requirements.

Hospitals and surgical teams use the system for intraoperative visualisation during open surgical procedures, including assessing tissue perfusion and flap circulation in plastic and micro-reconstructive surgery, supporting organ transplants, and visualising lymphatic flow.

Regulators in India registered the system with the Central Drugs Standard Control Organisation, whilst Thailand approved it through the Thai Medical Device Control Division.

Authorities in the Philippines approved it through the Centre for Device Regulation, Health and Research, and Bangladesh approved it through the Directorate General of Drug Administration.

UltraGreen previously received regulatory clearance for the system in Malaysia, Singapore, and New Zealand, and for Verdye (Indocyanine Green, pharmaceutical product) in the Philippines.

The press release also noted that regulators in the United States and Europe have also approved the system.

Declan Cassells, Chief Operating Officer of UltraGreen, said the approvals allow the company to engage with healthcare institutions, distributors, and clinical partners while complying with local frameworks.

Quek Mei Ling, Chief Business Officer (APAC), said South and Southeast Asia represent key healthcare markets and that the approvals help the company build long-term partnerships and support clinical education initiatives.