AccuMedical recently announced that two products it has developed—the Lattice flow diverter and the Grism stent retriever—have officially obtained CE-mark certifications under the EU Medical Device Regulation (MDR).
As such, multiple AccuMedical solutions for haemorrhagic stroke and ischaemic stroke have simultaneously gained access to the EU market, representing a milestone of great significance for its international development, as stated in a press release from the company.
The release goes on to note that the simultaneous certification of these two products “fully demonstrates” that AccuMedical’s product design, clinical value and quality management system comply with the regulatory requirements of the EU, and that its innovation capabilities have been acknowledged by internationally recognised regulatory authorities.
At the same time, AccuMedical further claims, the value of CE certification extends far beyond access to the European market alone. Through cross-border regulatory recognition mechanisms, local registration procedures in multiple regions—including Southeast Asia, the Middle East, Africa, and Latin America—can be significantly simplified, substantially improving overseas market access efficiency and providing strong momentum for the company’s global commercialisation.
The Lattice flow diverter is primarily indicated for the treatment of intracranial aneurysms. Incorporating AccuMedical’s original mechanical balloon delivery system and Miror surface modification technology, the product was approved for marketing through the Chinese National Medical Products Administration (NMPA) Innovative Medical Device Special Review Procedure in October 2022. It subsequently received regulatory approval in Vietnam in 2025 and Indonesia in 2026.
The Grism stent retriever is indicated for the treatment of acute ischaemic stroke. Its unique distal, closed, no-tip design effectively prevents clot escape, improves first-pass recanalisation rates, and helps secure valuable treatment time for patients, according to AccuMedical. This product was also approved for marketing by the Chinese NMPA in 2025.
