SEOUL, South Korea, July 27, 2020 /PRNewswire/ — VUNO Inc., South Korean synthetic intelligence (AI) developer and a member firm of the Born2Global Centre, introduced that VUNO Med®-Fundus AI™, its AI-based screening resolution for the fundus, gained the glory of being the first-ever Innovative Medical Device in Korea by the Ministry of Food and Drug Safety (MFDS) in recognition of its excessive stage of technological innovation. VUNO has proved its technological excellence in retinal fundus imaging evaluation.
The MFDS was unanimously elected to be the primary chair of Artificial Intelligence Medical Devices (AIMDs) on the International Medical Device Regulators Forum (IMDRF) held on June 25. All the credit score goes to the company’s steady effort to set the trail for the main regulatory framework of AI-based medical units by establishing pointers for approval and assessment of AI-based medical units in 2017 for the primary time on this planet.
With the MFDS taking on the helm, the Innovative Medical Devices are categorised and designated amongst candidates that excel in security and effectiveness in comparison with typical medical apparatuses and coverings. The following is included within the analysis standards: technological depth and tempo of technological innovation (technological innovation); enhancement in security and effectiveness in comparison with the present medical units (efficiency); and financial, social, and technological ripple impact (contribution to the general public good and industrial worth).
About VUNO Med®-Fundus AI™
VUNO Med®-Fundus AI™ analyzes retinal fundus pictures to detect greater than 12 lesions and classifies them for analysis. The 12 findings detected by the gadget are an all–encompassing set of medical data that’s essential to diagnosing a variety of retinal illnesses together with diabetic retinopathy, macular degeneration and glaucoma.
VUNO Med®-Fundus AI™ ranked high within the Automatic Detection Challenge on Age-related Macular Degeneration on the International Symposium on Biomedical Imaging (ISBI) 2020, following the profitable of the Diabetic Retinopathy – Segmentation and Grading Challenge on the similar competitors in 2018 and the Medical Image Computing and Computer Assisted Intervention (MICCAI) 2018 Retinal Fundus Glaucoma Challenge. In addition, a scientific analysis paper printed in Ophthalmology, one of the prestigious educational journals within the subject, validated the answer’s exceptional detection efficiency.
VUNO Med®-Fundus AI™, was authorized as a Class III medical gadget in April by the MFDS primarily based on the answer’s confirmed effectiveness and efficiency by a collection of scientific trials. Furthermore, in June, it gained the Class IIa CE marking in line with the European Union (EU) framework, thus permitting VUNO Med®-Fundus AI™ to be commercially launched in 27 EU member states and others that acknowledge the European CE mark.
For extra detailed data on VUNO, please go to https://www.vuno.co/.
PR Manager, VUNO lnc.
PR Manager, VUNO Inc.
PR Manager, Born2Global Centre
SOURCE Born2Global Centre