Galaxy Therapeutics achieves CE marking for the SEAL™ Embolization System
Galaxy Therapeutics has received CE marking for the SEAL™ Embolization System under the European Union Medical Device Regulation (EU MDR 2017/745), with certification effective July 29, 2026.
The SEAL™ Embolization System is a Class III medical device. The certification covers SEAL™ Base and SEAL™ ARC, its two implant configurations, and represents a major milestone in Galaxy’s mission to advance the treatment of intracranial aneurysms.
The conformity assessment was conducted by DQS Medizinprodukte GmbH, Notified Body 0297.
European availability
For information about product availability, physician training, and local distribution, please contact Galaxy Therapeutics. Availability is subject to applicable local requirements.
United States
Galaxy Therapeutics has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration. SEAL™ remains an investigational device in the United States.