Vuno, South Korean artificial intelligence (AI) developer and a member company of the Born2Global Centre, announced that the Vuno Med-Fundus AI, its AI-based screening solution for the fundus, was named the first-ever Innovative Medical Device in Korea by the country’s Ministry of Food and Drug Safety (MFDS) in recognition of its high level of technological innovation 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.
With the MFDS at the helm, candidates for the Innovative Medical Device designation are evaluated based on the following 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).
Vuno Med-Fundus AI was approved as a Class III medical device in April by the MFDS based on the solution’s proven effectiveness and performance through a series of clinical trials. Furthermore, in June, it gained the Class IIa CE marking according to the European Union (EU) framework, thus allowing VUNO Med-Fundus AI to be commercially launched in 27 EU member states and others that recognize the European CE mark.
For more information, visit Vuno.