Medical artificial intelligence (AI) solution development company VUNO Inc. and a member company of the Born2Global Centre, gained the Class IIa CE markings for five of their AI solutions.
The five CE marked solutions are: VUNO Med®-BoneAge™, VUNO Med®-DeepBrain™, VUNO Med®-Chest X-Ray™, VUNO Med®-Fundus AI™, and VUNO Med®-LungCT AI™. These products can now be commercialized and sold in 27 member states of the European Union, the Acceding countries as well as EFTA states. They can also make inroads into countries that recognize the European CE mark such as those in the Middle East, Asia, South and Central America, and Africa.
VUNO was assessed and deemed to meet EU safety and health protection requirements by a Notified Body based on a more stringent clinical validation standards and medical device guidelines. The efficacy and safety of those products demonstrated by a series of clinical research results and papers published in high impact journals and prestigious international seminars were of great help to satisfy the strict requirements.
Of the five MFDS (Ministry of Food and Drug Safety) approved products, four products (VUNO Med®-Fundus AI™, VUNO Med®-Chest X-ray™, and VUNO Med® – BoneAge™ and VUNO Med® Lung CT AI™) received regulatory approval based on the proven effectiveness of performance through clinical trials. With such a robust portfolio, it is anticipated that VUNO Med solutions are to be used as key diagnostic supporting tools across many different medical environments overseas.
Hyun-Jun Kim, CEO of VUNO explained that, “We have been taking proper measures to ensure that VUNO’s products obtain classification commensurate with their intended purposes as medical diagnostic supporting tools”. He also added that, “In this sense, obtaining CE certification for all five products holds a great significance, and this will be able to accelerate our push for much anticipated global supply of VUNO Med series all around the world.”
VUNO has been graining great traction at home and abroad with more than 100 active users of hospitals in Korea alone and is ready to deploy the CE marked products to international business partners and clients across different markets.
VUNO Med® – Fundus AI™
It automatically detects a variety of lesions from the fundus image and quickly classifies them for diagnosis. According to the research paper published in Ophthalmology, the solution’s clinical validation (AUROC) of the 12 findings resulted in in impressive range of 96.2 to 99.9%, and 94.7 to 98.0% with external datasets, proving its stable performance and meaningful accuracy.
VUNO Med® – LungCT AI™
It detects and quantifies early on pulmonary nodules that can progress to lung cancer, and automatically categorizes Lung-RADS to efficiently manage multiple pulmonary nodules.
VUNO Med® – Chest X-Ray™
It greatly enhances the screening function of chest X-rays by detecting the most common thoracic findings and diseases through chest X-ray images that are difficult to be identified at an early stage.
VUNO Med® – BoneAge™
VUNO’s first regulatory approved product, VUNO Med® – Bone Age, assists in assessing bone age based on a child’s left hand X-ray image, reducing diagnosis time and improving accuracy.
VUNO Med® – DeepBrain™
It segments brain regions using brain MRI data and quantifies the volumes of each region to provide atrophy volumetrics against normative database. It also generates an analysis report.
For more detailed information on VUNO, visit https://www.vuno.co/.