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 ...

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 ...

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 ...

Convatec Group plc secured CE mark and UKCA approvals for Convamatrix, its porcine placenta-based wound dressing designed for hard-to-heal wounds. The single use, skin substitute product is intended ...

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 ...

BASEL, Switzerland - Roche (SIX:RO, ROG; OTCQX:RHHBY) received CE Mark approval today for its Elecsys Apolipoprotein E4 test, the first in-vitro diagnostic immunoassay to identify the ApoE4 gene ...

Imperial Innovations Group plc has announced that portfolio company Veryan, a vascular disease specialist, has received CE Mark approval for the BioMimics 3D™ Stent. Its unique design mimics the ...