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CE Mark

Latest Headlines

Latest Headlines

Shockwave gets $40M to develop energy-delivering angioplasty balloon

Startup Shockwave Medical expects that its Lithoplasty balloon catheters will emerge as a pretreatment for calcified coronary lesions that's used instead of or prior to stenting. Now it's received $40 million to further advance toward that goal.

'Stealthy' Medina raises $6M in debt for cerebral aneurysm device after CE mark last fall

Menlo Park, CA-based Medina Medical has raised $6.2 million in debt to back its device development for vascular abnormalities, including a device specifically to treat cerebral aneurysms. It still declares itself in stealth mode on its site, despite the fact that it has already disclosed that it received a CE mark.

Medtronic joins St. Jude in leadless pacemaker market thanks to CE mark

Medtronic has officially joined the European leadless pacemaker market thanks to the CE-mark approval of its Micra Transcatheter Pacing System. It is one-tenth the size of conventional pacemakers, making it the world's smallest device in the overall category.

St. Jude's Portico TAVR gets CE mark reinstated after 'false alarm'

St. Jude Medical's transcatheter aortic valve replacement, or TAVR, cardiology device is now commercially available in Europe once again, after its CE mark was suspended following safety concerns about reduced valve leaflet mobility arising from the company's U.S. clinical trials.

Wall Street endorses Cyberonics, Sorin $3B merger to become neuromodulation, cardiac surgery player

Neuromodulation company Cyberonics and cardiovascular device player Sorin in an all-stock deal that now values the combination at $3 billion.

In a win for Spectranetics, Covidien's to-be-divested drug-coated balloon earns CE mark

Covidien today announced the CE mark granted for its Stellarex drug-coated balloon for peripheral artery disease. In addition to physically displacing the lesion with angiopolasty, Stellarex delivers the drug paclitaxel like many of its European competitors.

Roche launches point-of-care, PCR molecular diagnostic system from $450M deal for iQuum

Roche has launched the Laboratory-in-a-tube technology it acquired when it bought iQuum in April for $275 million up front and up to $175 million in milestone payments. Roche is making the system available in the U.S. and Europe.

GI Dynamics restructures, considers strategic options after EU shipment halt

Micro-cap obesity device company GI Dynamics is restructuring by cutting 10% of its workforce, including its CFO, as well as reviewing its strategic options. The Australian company expects to communicate its next move "over the next several months," GI Dynamics' president and CEO, Michael Dale, said in a statement.

Edwards gains option to acquire startup CardioKinetix in $50M financing

Edwards Lifesciences led a $50 million financing for catheter-based heart failure treatment startup CardioKinetix. The cash is expected to enable the completion of an ongoing U.S. pivotal trial for the company's Parachute Ventricular Partitioning Device with a PMA submission to the FDA to follow, as well as to finance international marketing efforts.

iRhythm wearable cardiac monitor gets CE mark, CardioLogic partners to sell it in U.K.

iRhythm has received a CE mark in Europe for its continuous heart monitoring Zio Service. The technology enables up to 14 days of continuous heart monitoring via a wireless patch; it includes analytical software, as well as report to the physician. In addition, iRhythm has partnered with cardiology distributor CardioLogic to market Zio in the U.K. for the diagnosis of atrial fibrillation and other cardiac arrhythmias.