Initial results of ReCor’s REDUCE First-In-Man clinical study presented at “TRenD 2012” transcatheter renal denervation scientific meeting as company gains CE mark for its PARADISE™ system.
CE Mark Approval
FDA Slow To Clear Products When EU Data Lacking
New paper compares CE vs FDA and concludes both need a makeover.
CE Mark For Edwards INTUITY Valve: Rapid Deployment Through Small Incision
Edwards Lifesciences Corporation, today announced that it has received CE Mark in Europe for its INTUITY Aortic Valve System.
Custom Spine’s Portfolio CE Marked
Custom Spine Inc has gained CE mark approval for all its products.
Buying Single-Use Pressure Transducer Could Save Money
This simple in-line transducer could have many applications including diagnosis of compartment syndrome, one of the most costly hazards in Orthopaedics.
CE Mark For Implantable Hemodialysis Access Device From Vital Access
Vital Access has its press release nicely in place, but we’d like to know how to contact the company let alone how to buy its new implantable hemodialysis access device.
CE Mark And Launch For Sorin’s New Pacing, Defibrillation And Left Ventricular Leads
New lead portfolio combined with Sorin Group’s innovative and intelligent devices provide full-featured systems for accurate management of arrhythmias and heart failure
Ranier Receives CE Mark Approval for Cadisc™-C Cervical Spinal Disc
Following Ranier’s earlier CE approval of its lumbar implant, the company has now secured CE Mark approval for its cervical implant, Cadisc™-C.
CE Mark For “Bi-Directional Retrieval” Inferior Vena Cava Filter
Crux Biomedical has announced it has received CE mark approval for its revolutionary inferior vena cava filter with bi-directional retrieval.
PIP Scandal Muddies Regulatory Debate
Opinion piece on how the PIP scandal is flushing out a mixed bag of arguments. But at least we’re thinking about the subject.
CE Mark For Articular Cartilage Diagnostic Assessment Tool
A new concept in non-destructive evaluation of articular cartilage has been CE marked by Biomomentum Inc.
CE Mark For WOUNDCHEK™Protease Status, First Point-of-care Diagnostic Test for Chronic Wounds
Systagenix Wound Management has announced that it has gained CE mark status for its WOUNDCHEK™ Protease Status diagnostic tool to aid wound assessment.
CE Mark And Launch For Medtronic’s Endurant® II AAA Stent Graft System
Medtronic’s Endurant® II Stent Graft to repair Abdominal Aortic Aneurysms without open surgery.
Smallest, Lightest, Quietest, Durable Insulin Pump Gains CE Mark
D.Medical has achieved CE mark status for its Spring™ Zone Insulin Delivery System featuring technology which is claimed to offer superior blockage and detachment detection in a device which is small, light, quiet and durable.
Linx Laparoscopic Anti-Reflux Device Gains FDA Panel Support
Sphincter specialist Torax Medical Inc. has taken a significant step towards FDA approval for its Linx device, designed for treatment of Gastro-Oesophageal-Reflux Disease by gaining the unanimous support of FDA’s 9 member advisory panel.
CE Mark For App To Improve Burns Assessment
Mobihealth News has reported on what may be the first medical app to gain CE Mark approval in the UK.