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).
About VUNO Med®-Fundus AI™
VUNO Med®-Fundus AI™ analyzes retinal fundus images to detect more than 12 lesions and classifies them for diagnosis. The 12 findings detected by the device are an all–encompassing set of medical information that is crucial to diagnosing a wide range of retinal diseases including diabetic retinopathy, macular degeneration and glaucoma.
VUNO Med®-Fundus AI™ ranked top in the Automatic Detection Challenge on Age-related Macular Degeneration at the International Symposium on Biomedical Imaging (ISBI) 2020, following the winning of the Diabetic Retinopathy – Segmentation and Grading Challenge at the same competition in 2018 and the Medical Image Computing and Computer Assisted Intervention (MICCAI) 2018 Retinal Fundus Glaucoma Challenge. In addition, a clinical research paper published in Ophthalmology, one of the most prestigious academic journals in the field, validated the solution's remarkable detection performance.
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.