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.