Vuno said Tuesday that five of its artificial intelligence-based medical devices have won the Conformite Europeenne (CE) certification as a class 2a medical imaging solution.
The five are VUNO Med-BoneAge, VUNO Med-DeepBrain, VUNO Med-Chest X-Ray, VUNO Med–Fundus AI, and VUNO Med–LungCT AI.
|Vuno has won CE approval for five of its medical imaging solutions. (Vuno)|
The company can now distribute and commercialize its medical solutions not only in EU member nations but also its associate members and the members of the European Free Trade Association (EFTA). Vuno can also enter other regions, including the Middle East, Asia, Latin America, and Africa, which recognize CE marking.
The Ministry of Food and Drug Safety has also approved all five CE certified solutions. Four of them showed efficacy in clinical trials conducted at large domestic medical institutions.
Vuno said that the latest CE certification has confirmed that domestic clinical outcomes could produce valid results in the European medical environments as well.
“We have been going through the licensing process to acquire appropriate grades for our medical solutions that meet the objectives of medical practitioners,” Vuno CSO Kim Hyun-jun said. “We will manage to supply our medical solutions to countries under discussion to use the products.”