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K-BioMed Pioneer: VUNO Med®-Fundus AI™ Becomes Korea's First-ever Innovative Medical Device

Wednesday, July 29, 2020

VUNO Inc., South Korean artificial intelligence (AI) developer and a member company of the Born2Global Centre, announced that VUNO Med®-Fundus AI™, its AI-based screening solution for the fundus, gained the honor of being the first-ever Innovative Medical Device in Korea by the Ministry of Food and Drug Safety (MFDS) in recognition of its high level of technological innovation. VUNO has proved its technological excellence in retinal fundus imaging analysis.

The MFDS was unanimously elected to be the first chair of Artificial Intelligence Medical Devices (AIMDs) at the International Medical Device Regulators Forum (IMDRF) held on June 25. All the credit goes to the agency's continuous effort to set the path for the leading regulatory framework of AI-based medical devices by establishing guidelines for approval and review of AI-based medical devices in 2017 for the first time in the world.

With the MFDS taking at the helm, the Innovative Medical Devices are classified and designated among candidates that excel in safety and effectiveness compared to conventional medical apparatuses and treatments. The following is included in the evaluation criteria: technological intensity and pace of technological innovation (technological innovation); enhancement in safety and effectiveness compared to the existing medical devices (performance); and economic, social, and technological ripple effect (contribution to the public good and industrial value).