St. Jude Medical (NYSE:STJ) today said it added MR-conditional labeling to the CE Mark for its Prodigy spinal cord stimulator, which is designed to treat chronic pain. The approval means the company can market the device for patients who need head and extremity MRI scans. Little Canada, Minn.-based St. Jude claimed the Prodigy MRI as the smallest MR-conditional […]
Biotronik said yesterday it won CE Mark approval in the European Union for 2 next-generation MRI-safe pacemakers. The new devices are compatible with up to 3 tesla MRI scanning machines, the company said. Around 20-30% of MRI machines worldwide are 3T machines, Biotronik said, and the number of these devices is growing. “The benefits of 3 […]
Emba Medical said today it won CE Mark approval in the European Union for its Hourglass peripheral embolization plug device. The Dublin, Ireland-based embolization plug maker said the device features over-the-wire delivery, which the company claims increases precision of placement. “This is the 1st integrated, over-the-wire device designed for peripheral embolization procedures. The goal with over-the-wire […]
Masimo (NSDQ:MASI) said yesterday that it won CE Mark approval in the European Union for its Root patient monitoring platform with blood pressure and temperature capabilities. The Irvine, Calif.-based company’s device is designed to allow clinicians to non-invasively measure arterial blood pressure as well as temperature while staying connected to electronic health records, Masimo said. “Root and […]
Arterial Remodeling Technologies said it won CE Mark approval in the European Union for its bioreabsorbable stent for treating coronary artery disease.
Stentys this week said it won a CE Mark ahead of schedule for its latest self-apposing coronary stent, a product that will be used with delivery system technology it acquired last June.