European Commission Grants CE Mark for PQ Bypass Devices March 13, 2017 The bypass delivers unobstructed, pulsatile flow from the superficial femoral artery ostium to the popliteal artery. Read More
FDA Expands Clearance for Spineology’s Expandable Interbody Fusion System March 13, 2017 The device implant is inserted into the disc space and expanded. Read More
Autonomic Technologies Gains Expanded Indication of CE mark for Pulsante SPG Microstimulator System March 10, 2017 The microstimulator device delivers as-needed relief for migraine patients. Read More
FDA Awards Clearance to W. L. Gore & Associates’ Controlled Expansion for TIPS Procedures March 9, 2017 Physicians can balloon up as needed during implantation to optimize the diameter. Read More
Zoll Hospital Wearable Defibrillator Receives Premarket Approval from the FDA March 9, 2017 The device delivers treatment within 60 seconds. Read More
FDA Clears Intellijoint Surgical’s Intellijoint HIP Anterior Application March 8, 2017 The device is a 3D mini-optical navigation solution. Read More
Beckman Coulter Diagnostics Gains FDA Clearance for its DxC 700 AU Chemistry Analyzer March 8, 2017 The analyzer is designed to reduce the number of test-processing steps by 30 percent. Read More
Alere Acquires FDA CLIA Waiver for Alere I RSV Rapid Molecular Test March 7, 2017 The test was FDA cleared in August 2016. Read More
FDA Approves Spectral's Third PMA Module for Toraymyxin Treatment of Endotoxemic Septic Shock March 7, 2017 PMX removes endotoxin from the blood. Read More
BTG Gains CE Mark for Drug-Eluting Bead March 7, 2017 The bead can be loaded with doxorubicin or irinotecan. Read More
FDA Grants Marketing Clearance to Nephros’ Endotoxin 10" Filter March 6, 2017 The filter is designed to provide hemodialysis quality water to dialysis machines. Read More
NxStage Medical Awarded CE Mark for its NxGen Hemodialysis System March 6, 2017 The touchscreen system has an integrated blood pressure monitor. Read More