Pressmeddelanden, rapporter och bolagsmeddelande för Cessatech

Cessatech A/S announced that it received a positive opinion from a Notified Body under the EU Medical Devices Regulation for its product CT001. The technical documentation for CT001 was deemed adequate to meet safety and performance requirements. This opinion is part of the EMA approval process and indicates that the product meets EU standards for safety and efficacy. Cessatech's CSO, Martin Juhl, expressed pride in the team's efforts and highlighted the innovative use of the Interactive Online Review Process. CEO Jes Trygved noted that this achievement brings the company closer to getting CT001 approved in Europe for children aged 1-17, in collaboration with commercial partner Proveca. The MDR process has seen over 3,000 certificates and opinions completed since 2021, despite a significant backlog.