iVascular’s Luminor 18 Secures CE Mark Approval May 20, 2016 The balloon is compatible with 0.018-inch guidewires. Read More
FDA Approves Roche’s PD-L1 Biomarker Assay May 20, 2016 The assay determines PD-L1 status through immune cell staining. Read More
Boston Scientific Gains FDA Approval for Precision Montage System May 19, 2016 The company plans on introducing the device Friday. Read More
Millennium Dental Secures FDA Clearance for Tissue Regeneration May 18, 2016 The procedure uses laser energy to kill bacteria and promote regrowth of oral tissue. Read More
Ascensia Diabetes Care Garners CE Mark for Glucose Monitoring Systems May 17, 2016 Both meters, along with the app, will be launched initially in two European markets. Read More
First Ray Secures FDA Clearance for CortiClamp May 16, 2016 The device uses a “bi-cortical clamping force.” Read More
Bone Index Gains FDA Clearance for Bindex May 16, 2016 The instrument measures cortical bone thickness of the tibia. Read More
FDA Clears Xtant’s Certex Spinal Fixation System May 13, 2016 The clearance extends use of the screws to include posterior cervical spine procedures. Read More
BD Earns CE Mark for Vaginal Panel May 13, 2016 The test is designed to detect microorganisms present in vaginitis. Read More
EndoGastric Solutions’ EsophyX Device Nabs FDA Clearance May 13, 2016 The original model was cleared in 2007. Read More
Health Canada Approves STAAR Surgical’s EVO Visian ICL May 13, 2016 The lens is implanted inside of the eye between the iris and the natural lens. Read More
FDA Greenlights Biofrontera’s Drug-Device Combo for Actinic Keratosis May 13, 2016 The drug-device combo uses photodynamic therapy to target lesions caused by prolonged exposure to UV rays. Read More