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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

Paris, January 26, 2026 – HighLife SAS, a leading MedTech company focused on transcatheter solutions for structural heart disease, today announced that it has received CE Mark approval for the ...

The Elecsys ApoE4 test is the first CE marked in-vitro diagnostic immunoassay to identify individuals carrying the ApoE4 genetic variant using a simple blood sample. The test offers a fast, reliable ...

LAUSANNE, Switzerland--(BUSINESS WIRE)--Biospectal, the remote monitoring and biosensing software company, today announced it has received European CE MDR Class IIa medical device certification for ...

In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA ...

Until now, confirming ApoE4 carrier status in Alzheimer's patients has relied on molecular DNA testing. The Elecsys ApoE4 test offers a simple, fast and reliable option, using a minimally-invasive ...