CE Mark

Latest Headlines

Latest Headlines

Philips to launch pneumonia Dx wearable to prevent child deaths in poorer countries

Almost one million childhood deaths are attributed to pneumonia annually, leading UNICEF to issue a call in 2011 for product innovation to create a respiratory monitor. Now, Royal Philips is almost ready to launch its Children's Automated Respiration Monitor that is designed to address those needs.

Europe grants its first CE mark for leadless pacemaker to treat left ventricle

EBR Systems' WiSE leadless pacemaker just earned a CE mark, becoming the first device in the class approved for improving left ventricular function. Medtronic and St. Jude Medical also offer leadless pacemakers, but they are implanted in the heart's right ventricle.

Sientra off by more than 50% after it discloses CE mark suspension for its contract manufacturer

Breast implant company Sientra saw its valuation cut in half on news that its contract manufacturer Silimed has had its CE mark suspended by the U.K. Department of Health. The move came after German regulators conducted an inspection of a Brazilian manufacturing plant--and regulators found that "the surfaces of some implants were contaminated with particles."

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.