CE Mark

Latest Headlines

Latest Headlines

Edwards Lifesciences wins CE mark for aortic valve system

Edwards Lifesciences won a CE mark for its innovative aortic valve system. European approval for the device comes at a critical moment for the company, as it attempts to strengthen its hold on foreign markets and stay a step ahead of its competition.

Boston Scientific will expand the use of a key esophageal stent in Europe

Boston Scientific nabbed a new CE mark that allows one of its esophageal stents to be used to treat narrowing of the esophagus caused by benign scar tissue--another win as the company seeks to restore steady revenue expansion after a years-long slump.

Stentys' self-apposing cardiac stent gains expanded CE mark indications

Stentys now has key CE mark approval to use its self-apposing stent to treat acute heart attacks in a broader class of patients.

Veniti reels in $9.7M for vein treatment device work

Veniti, a Missouri device startup developing venous disease treatments, has nailed down more than $9.7 million of an anticipated $12 million round of venture financing from 15 investors, according to a regulatory filing.

Medtronic launches spinal surgery tool in Europe

Medtronic is debuting a new surgical tool in Europe designed to help surgeons perform osteotomies to treat severe spinal curvature in adults. The launch comes in tandem with a new CE mark.

Teleflex snags CE mark for balloon catheter

Teleflex picked up European approval to market its GPSCath device, designed to prop open vessels and reduce procedure times for vascular interventions.

Abbott CE mark covers extra-long stent size

In the fiercely competitive global stent market, Abbott seems to view size as mattering most.

Shorter Tryton side branch stent wins CE mark

Tryton Medical won a CE mark for a short version of its Side Branch Stent to treat bifurcated lesions, a crucial step toward reaching more patients and pursuing the company's U.S. approval pathway.

St. Jude gains CE mark for quadripolar CRT pacer

St. Jude Medical ($STJ) scored European regulatory approval for a new quadripolar cardiac resynchronization therapy pacemaker. And with an immediate commercial rollout, the company gains another product that could help reverse sluggish revenue in the sector.

Apollo Endosurgery wins first EU approval

Apollo Endosurgery is making its first foray into Europe, backed by a new CE mark for two of its products that enable incision-less surgery while using a flexible endoscope.