European rules for obtaining CE marking on products sold to EU Member States or in the EEA - conditions and product requirements for the conformity marking ...

With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better ...

Memphasys Ltd ( ($AU:MEM) ) has provided an update. Memphasys has secured CE Mark approval under the European Union Medical Device Regulation for ...

SAN DIEGO--(BUSINESS WIRE)--Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, ...

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 ...

Jenscare Scientific Co. Ltd. Class H ( ($HK:9877) ) has provided an announcement. Jenscare Scientific has submitted a registration application for ...

Roche’s Elecsys pTau181 test has secured CE Mark approval, marking a development in ruling out Alzheimer's disease. The minimally invasive blood test measures phosphorylated Tau (pTau) 181 protein, a ...

Only a month after Getinge announced the suspension of the CE marks allowing it to sell its heart-lung support and permanent life support systems in Europe, the Swedish devicemaker has temporarily ...

DUBLIN, Ireland, May 20, 2022 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) has achieved a CE Mark for its 10-minute Covid-19 antigen test. This CE mark allows for use by healthcare ...