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 ...

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, ...

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 ...

MAQUET Cardiovascular today announced that it has received European CE Mark approval for its CARDIOROOT aortic graft. An innovative, one-piece design, aortic root graft, CARDIOROOT will be used by ...

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 ...

With approval, the HeartMate 3 System offers physicians in Europe the most advanced ventricular assist technology available to support the management of patients with advanced stage heart failure ST.

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 ...