Roche Scores FDA Approval for HIV-1 Viral Load Test December 21, 2015 Clinicians will use the test to manage and treat patients infected with HIV-1. Read More
Torax Awarded FDA Approval for Fecal Incontinence System December 18, 2015 The implant contains a series of titanium beads with magnetic cores to minimize involuntary opening of the anal canal. Read More
Luminex Nabs FDA Clearance for Respiratory Pathogen Panel December 18, 2015 The assay detects 20 clinically relevant viral and bacterial respiratory pathogens. Read More
Life Spine Nabs FDA’s Blessing for Gruve Anterior Cervical Plate System December 17, 2015 The system allows for extreme bone screw angulation and large graft windows. Read More
K2M Wins FDA 510(k) Clearance, CE Mark for Everest Spinal System December 17, 2015 The screw system features rigid closed-top break-off extension tabs for minimally invasive rod passage. Read More
RegenScientific Wins CE Mark for Renú Soft Tissue Implant December 16, 2015 The implant is for the treatment of lipoatrophy, vocal fold insufficiency and soft tissue augmentation. Read More
Svelte Gets CE Mark for SLENDER Integrated Delivery System December 15, 2015 The system is designed for the treatment of coronary artery disease. Read More
Arsenal Medical Secures $14M to Support ResQFoam Development December 14, 2015 ResQFoam works to stop massive blood loss in patients with severe internal bleeding within the abdomen. Read More
BTG Wins FDA Clearance for LC Bead LUMI December 14, 2015 LC Bead LUMI is a radiopaque embolic bead for the embolization of hypervascular tumors and arteriovenous malformations. Read More
Avita Scores FDA EAP Designation for ReCell December 14, 2015 The device enables clinicians to rapidly regenerate healthy skin. Read More
EDAP’s Focal One Ultrasound Device Wins Russian Approval December 11, 2015 The robot-assisted device is designed for the focal therapy of prostate cancer. Read More
Medtronic Scores Additional Approvals for Infuse Bone Graft December 11, 2015 The product can now be marketed for use with certain spine implants. Read More