Noul wins Saudi FDA approval for malaria diagnosis device

AI Malaria Diagnostic Device ‘MyLab.’ [Courtesy of Noul]

South Korean AI healthcare startup Noul announced on Monday that its AI-powered medical device software and cartridges have officially secured marketing approval from the Saudi Food and Drug Authority (SFDA).

Noul’s malaria diagnostic software and cartridges, classified as Class 3 medical devices, along with its blood analysis assistance software and cartridges, designated as Class 1 devices, received the SFDA’s green light. This milestone sets the stage for Noul’s entry into the Saudi market, and it has further plans to expand across the Middle East.

The Saudi medical device market is forecast to grow at a steady 4.6 percent annually and is expected to be valued at $2.61 billion by 2026. Thanks to rising demand and substantial government investment, the region is emerging as a promising landscape for Korean businesses looking to expand globally.

In line with its broader market ambitions, Noul is working to obtain regulatory approvals in regions including North America, Indonesia, and Malaysia. It also aims to streamline its market entry process and capitalize on its existing certifications, including the European CE mark, to speed up commercialization efforts.

Noul’s AI-driven malaria diagnostic device, MiLab, also continues to turn in an exceptional performance, surpassing human experts and meeting the growing global need for precise malaria diagnostics. MiLab boasts a 98.86 percent accuracy rate, is widely adopted in hospitals and research institutions across Africa and Europe and backed by clinical studies that have been published in leading international journals.