Tag:

CE Mark

Latest Headlines

Latest Headlines

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.

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.