Tag:
CE Mark
Latest Headlines
Latest Headlines
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.
Gynesonics draws in $21M Series D to advanced uterine fibroid ablation device
Gynesonics' ablation device to treat uterine fibroids is drawing major investor interest. Switzerland's HMB Partners and others will fund the California company's $21 million Series D financing round to help advance the product in several ways.
Medtronic gets FDA nod for next-gen, MRI-friendly pacer
Medtronic gained FDA approval for what will become its second MRI-friendly pacer in the United States, and only the second device of its kind to gain a regulatory nod here.
Swiss stent developer grabs $4.3M series B in crowded EU market
Swiss coronary stent developer Qvanteq is reeling in more than $4.3 million in series B financing, representing the emergence of yet another stent player in an intensely competitive European market.
HeartWare reports HVAD pump mechanical problem
HeartWare International ($HTWR) reports that at least 11 of 2,900 implants involving its celebrated HVAD heart pump have erupted with a troubling mechanical problem – a part that could become partially separated from the main unit after extended use.
True Diagnostics revs up EU prostate cancer Dx launch
True Diagnostics gained a CE mark for its new quantitative prostate cancer diagnostic test, and the California startup will initially start selling it through distribution partners in Germany, the U.K., France, Italy and Spain.
Medtronic grabs CE mark for next-gen ICD
Medtronic snagged CE mark approval for its Evera line of ICDs, planning to launch devices the company says offer increased longevity, lower risk of shock and a 30% reduction in skin pressure.
Biosensors International fires latest round in EU stent battle
The battle between stent manufacturers is heating up in Europe, with Biosensors International firing the latest salvo. The Swiss company disclosed that it gained a CE mark for BioFreedom, its polymer-free drug-coated stent.
