Medical AI solutions company VUNO obtains CE Mark for five of its solutions

These solutions can now be commercialized and sold in 27 member states of the European Union, the Acceding countries as well as EFTA states.
By Dean Koh
12:30 AM

Founded in South Korea in 2014, medical AI solutions development company VUNO announced that they have received the Class IIa CE markings for five of their AI solutions. 

The five CE marked solutions are: 

  • VUNO Med –BoneAge - VUNO's first regulatory approved product, which assists in assessing bone age based on a child's left-hand X-ray image, reducing diagnosis time and improving accuracy.
  • VUNO Med -DeepBrain, which segments brain regions using brain MRI data and quantifies the volumes of each region to provide atrophy volumetrics against normative database and also generates an analysis report.
  • VUNO Med -Chest X-Ray, which 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 –Fundus AI – it automatically detects a variety of lesions from the fundus image and quickly classifies them for diagnosis.
  • VUNO Med –LungCT AI, which detects and quantifies early on pulmonary nodules that can progress to lung cancer, and automatically categorizes Lung-RADS to efficiently manage multiple pulmonary nodules.

According to Vuno, 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.

Of the five MFDS (Ministry of Food and Drug Safety, South Korea) 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.


Earlier this month, Lunit, a South Korea-founded medical AI company which specializes in developing AI solutions for radiology and oncology said that its AI solution for breast cancer, Lunit INSIGHT MMG, has been CE certified, Healthcare IT News reported


"We have been taking proper measures to ensure that VUNO's products obtain classification commensurate with their intended purposes as medical diagnostic supporting tools. 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," explained Hyun-Jun Kim, CEO, VUNO. 

Want to get more stories like this one? Get daily news updates from Healthcare IT News.
Your subscription has been saved.
Something went wrong. Please try again.