Biophor Diagnostics Receives 510(k) Clearance for Seventh Oral Fluid Screening Assay October 20, 2015 The assay is for d-methamphetamine at a 50 ng/mL cutoff. Read More
Luminex Receives CE-IVD Marking for NxTAG Respiratory Pathogen Panel October 20, 2015 The panel detects 21 clinically relevant viral and bacterial respiratory pathogens. Read More
ViewRay Receives Korean Approval for Radiation Therapy System October 19, 2015 The system uses MRI technology to provide high-quality images during treatment. Read More
Lightpoint receives CE Mark for LightPath Imaging System October 19, 2015 The system is designed to ensure removal of all cancerous tissue. Read More
SonaCare Medical Receives FDA De Novo Clearance for Sonablate 450 October 16, 2015 The device was approved for the ablation of prostate tissue. Read More
FDA Clears Stryker’s VertaPlex HV October 16, 2015 Sacral insufficiency is an underdiagnosed condition in the elderly population. Read More
Edwards Lifesciences Wins FDA Approval for Aortic Valve-in-Valve Procedures October 16, 2015 A study found a 86.6 percent survival rate for patients. Read More
FDA Approves Endologix’s Bifurcated Endograft System October 14, 2015 The system treats abdominal aortic aneurysms. Read More
Abbott Releases Clinical Results of Absorb III Trial October 14, 2015 The company’s fully dissolving heart stent met its primary endpoint. Read More
Ortho Clinical Diagnostics Receives CE Mark for Ortho Vision Max October 14, 2015 The system is a fully automated blood analyzer for high-volume transfusion medicine laboratories. Read More
Varian Receives CE Mark for ProBeam Proton Therapy System October 13, 2015 The system treats cancer with proton beams, reducing side effects. Read More
CardioKinetix Receives South Korean Regulatory Approval for Parachute System October 13, 2015 The ventricular partitioning system is intended for use following a heart attack. Read More