Noul, a Korean company specializing in AI-based blood and cancer diagnostics, said Friday that its AI-powered medical software and cartridge have received distribution approval from Indonesia's Ministry of Health.
This is Noul's first regulatory approval for its blood analysis products in an ASEAN country. The company plans to accelerate its global expansion with its blood analysis and malaria diagnostic software and cartridge.
Noul has already obtained distribution permits in Indonesia, Malaysia, and the Philippines, and added that it is close to securing approvals in other key markets, including Thailand and Vietnam.
The company noted that the importance of this approval is amplified by the increasingly stringent medical device regulations within ASEAN. Indonesia follows the ASEAN Medical Device Directive (AMDD), which seeks to establish international standards for the regulation and safety of medical devices.
"Indonesia, the world's fourth most populous country with 280 million people, makes up 36 percent of the ASEAN economy and has an annual growth rate of over 5 percent. Its healthcare market, particularly in telemedicine, is growing rapidly, with growth rates exceeding 600 percent," said Noul’s chief business officer, Kim Tae-hwan. "Given the country’s rapid digital transformation in healthcare, we are confident in the seamless integration of our miLab products."
Indonesia faces a significant shortage of medical professionals, with only 0.76 doctors per 1,000 people. Its geography, consisting of numerous islands, poses challenges for the regional healthcare system. Noul's miLab, the only digital microscopy-based diagnostic solution included in the WHO malaria guidelines, provides expert-level diagnostic accuracy on-site and supports remote result viewing, making it a highly effective solution even in areas with limited medical infrastructure, the company added.
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