The data from the Phase III LUNAR trial, which assessed the device’s treatment efficacy and safety, supported the approval.

Vivasure Medical Ltd. received CE mark approval for its Perqseal Elite vascular closure system which manages bleeding complications associated with large-bore arterial vessel closure. The sutureless, ...

The regulatory approval in the EU comes approximately six months after Novocure secured FDA approval of the system.

NEW YORK – Roche announced on Wednesday that it has received CE marking for its Chest Pain Triage algorithm to help rule in and rule out heart attacks in the emergency department.

The replacement system is launching into markets already served by repair devices, namely Edwards’ Pascal and Abbott’s ...

Novocure (NVCR) announced that Optune Lua has received a CE Mark for the treatment of adult patients with metastatic non-small cell lung cancer ...

Optune Lua is now approved for use concurrently with immune checkpoint inhibitors or docetaxel in adult patients with metastatic NSCLC who have progressed ... based regimen CE Mark approval ...

Optune Lua received a CE Mark for metastatic non–small cell lung cancer with immune checkpoint inhibitors or docetaxel.

Vivasure Medical announced today that it received CE mark approval for its PerQseal Elite vascular closure system.