DEEPVESSEL FFR® received the first CE marking certification for deep neural network-based product of China
Keya Medical announced on September 21, 2018 that DEEPVESSEL FFR® received ISO 13485:2016 certification for Medical Device and Quality Managements Systems as well as its CE Mark Certification after a series of on-site audits and evaluations by its notified body, DEKRA. Keya Medical is now the first artificial intelligence medical group in China to have obtained CE certification for a product based on deep neural networks.
Receiving CE certification is a mandatory safety certification for products to be sold within the European Economic Area (EEA), and serves as a passport for manufacturers and service providers to enter the European Union market. Receiving CE Marking Certification guarantees that a manufacturer’s product meets the essential requirements of all relevant European Medical Device Directives. This means that DEEPVESSEL FFR® is officially qualified for commercial use in the European market, which will lay the foundation for the commercialization of other deep neural network medical products in the future.