This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

HighLife Receives CE Mark Approval for its TMVR SolutionParis, January 26, 2026 – HighLife SAS, a leading MedTech company focused on ...

Cerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation ...

SAN DIEGO, CA / ACCESS Newswire / October 28, 2025 / Modular Medical, Inc. (Nasdaq:MODD) ("Modular Medical" or the "Company"), a leader in innovative insulin delivery, today announced that it is ...

Femasys Inc. announced the achievement of CE mark certification for the FemBloc delivery system, marking it as the first regulatory approval in the world for a non-surgical permanent birth control ...

Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took ...

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, today announced it received CE Mark certification for its Tasso+™ device, a ...

SAN DIEGO, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Beam Global (BEEM), (Nasdaq: BEEM), a leading provider of innovative and sustainable infrastructure solutions for the electrification of transportation and ...

GenesisX was approved in Europe and is set to be approved in the US late this year. The new robot is a giant leap forward in accessibility. Stereotaxis should get MAGiC approved in Europe in October.

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced today the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood ...

B-rayz AG received CE mark for its Data Adaptive Neural Artificial Intelligence (DANAI) technology that helps clinicians with breast cancer detection. The company hopes that DANAI, which introduces a ...

ASP GmbH ("ASP"), a division of Fortive (NYSE: FTV), in collaboration with FUJIFILM Healthcare Europe GmbH, proudly announces ...