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 ...

MALAKOFF, France--(BUSINESS WIRE)--Regulatory News: THERACLION (Paris:ALTHE) (Euronext Growth, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, today ...

The Medicines and Healthcare products Regulatory Agency (MHRA) is hoping to address a critical regulatory issue for medical ...

Beam Global announced that its products, including EV ARC™, BeamBike™, BeamWell™, and BeamPatrol™, have received the CE mark, which signifies compliance with European Union health, safety, and ...

InspireMD, Inc. NSPR recently announced its receipt of CE Mark recertification under the European Union’s (EU) new Medical Device Regulation (MDR) regulatory framework. The CE Mark certification under ...

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.

Optune Lua received a CE Mark for treating metastatic NSCLC, used with immune checkpoint inhibitors or docetaxel after progression on a platinum-based regimen. The phase 3 LUNAR trial showed ...

The Canadian devicemaker Kardium has received European approval for its spherical heart ablation system designed to treat atrial fibrillation. The company’s Globe catheter array consists of 122 ...