SI-Bone, Inc. Gains FDA Clearance of the iFuse-3D Implant June 13, 2017 The device has a fenestrated design and enhanced porous surface that resembles the trabecular structure of cancellous bone. Read More
Techlab Wins FDA Clearance for E. Histolytica Quik Chek Device June 13, 2017 The assay specifically detects pathogenic E. histolytica. Read More
Etiometry Acquires FDA Clearance to Expand the Indications IDO2 Index Powered by Risk Analytics June 13, 2017 The index device continuously assesses the patient-specific risk of inadequate oxygen delivery by computing an IDO2 index. Read More
Thermo Scientific’s CEDIA Buprenorphine II Assay Receives FDA Clearance and CE Mark June 12, 2017 Buprenorphine is an alternative to methadone in the treatment of opioid addiction. Read More
Bio-Rad Labs Receives FDA Clearance for BioPlex 2200 Syphilis Total & RPR Assay June 12, 2017 The assay provides laboratories an automated Treponemal/non-Treponemal dual assay. Read More
Milestone Scientific Gains FDA Clearance for CompuFlo Epidural Instrument June 12, 2017 The device allows for anesthesiologists to quantitatively determine and document the pressure at the needle tip in real time. Read More
GenMark Wins FDA Market Clearance for Its ePlex Instrument and Respiratory Pathogen Panel June 12, 2017 The ePlex RP panel detects more than 20 viral and bacterial pathogens. Read More
FDA Clears Qiagen's QuantiFeron-TB Gold Plus Blood Testing Device June 9, 2017 The device measures a broader range of immune response. Read More
FDA Clears Thornhill Medical's Portable Emergency Life Support System June 8, 2017 The system has a built-in oxygen concentrator. Read More
AngioDynamics Wins FDA Clearance for Solero Microwave Tissue Ablation System June 8, 2017 The Solero MTA system is not intended for cardiac use. Read More
Zebra Wins CE Mark for Its Deep Learning Imaging Analytics Engine June 7, 2017 The device provides automated analysis of imaging data. Read More
Hologic's Genius 3D Mammography Exam Gets FDA Clearance June 7, 2017 The 3D device can detect up to 65 percent more invasive breast cancers. Read More