CE Mark

Latest Headlines

Latest Headlines

Reva raises $25M to get CE mark for bioresorbable scaffold

Reva Medical has raised $25 million in debt from Goldman Sachs and Senrigan Capital. The financing had been months in the making and is expected to enable the development-stage company to get its latest bioresorbable stent on the market in Europe.

Medtronic announces launch of new drug-eluting stent following CE mark

Medtronic kicked off the commercialization of its Resolute Onyx drug-eluting stent in Europe today. The device will also be launched in selected countries around the world that recognize the CE mark, but not the U.S., where FDA approval is required.

Medrobotics raises $20M to pursue FDA approval, EU marketing

Medrobotics, a surgical products company focused on medical robotics, raised $20 million in equity financing.

Medtronic gains approval, launches Tyrx antibacterial envelope in Europe

Already cleared by the FDA last year, the Tyrx Absorbable Antibacterial Envelope has won a CE mark for use with cardiac devices, and Medtronic has launched it in Europe.

Medtronic receives CE mark for upgraded CoreValve TAVR

Medtronic said that its recent CE mark for its CoreValve Evolut R System for transcatheter aortic valve implantation paves the way for the option to recapture or reposition artificial valves during heart surgery. The new feature is an advance in the relatively new arena of less-invasive heart surgery for patients who cannot withstand the rigors of open heart procedures.

Abbott glucose monitor eliminates finger sticks, receives CE mark

Getting rid of the finger stick for diabetics while maintaining sufficient accuracy without calibration is a long-held industry goal and could prove a boon to patients.

Metal-based bioresorbable vascular closure device obtains CE mark

Transluminal Technologies has announced it has received a CE mark for the bioresorbable Velox CD Vascular Closure Device for hemostatis, or stopping bleeding, in the thigh's femoral arterty following procedures involving needle puncture.

Abbott gets EU go-ahead for implant in aging eyes

Cataracts are big business for Abbott. It's ready to roll out the latest in its line of implantable Tecnis lenses in Europe after recently receiving a CE Mark for the product, which will be used to treat cataract patients who may also have a diminished ability, due to aging, to focus on near objects (presbyopia).

Medtronic wins a CE mark for its NC Euphora balloon catheter

Medtronic received a CE mark for the NC Euphora balloon catheter, a device designed to ensure that drug-eluting stents are fully apposed following implantation. 

Elixir gets a CE mark for its latest bioresorbable stent

Elixir Medical has received a CE mark for its DESolve 100 novolimus-eluting bioresorbable coronary scaffold, named after its 100-micron strut profile and designed to degrade within an year.