Japan Green Lights Gore Excluder Iliac Branch Endoprosthesis May 25, 2017 The IBE is an iliac branch solution is indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. Read More
Quidel Awarded PMDA Approval for Its Sofia Influenza A+B Assay May 25, 2017 Sofia analyzer and Sofia influenza A+B FIA uses software and fluorescent chemistry to yield results. Read More
SCIEX Gains FDA Clearance for Vitamin D Assay Kit for Mass Spectrometry May 24, 2017 The assay is intended for in vitro diagnostic use. Read More
Soterix Medical Gains FDA Clearance for IontoDC System May 23, 2017 The device is used to direct current to introduce ions of soluble salts to the body. Read More
Avacen Medical Wins CE and Health Canada Approval for Pain Treatment Device May 23, 2017 The device infuses heat into the circulatory system to provide muscular relaxation. Read More
EMED Technologies Wins Expanded Indication for Syringe Infusion System May 23, 2017 The device administers human plasma-derived immunoglobulin biologics. Read More
Otsuka and Proteus Digital Health Resubmit Application to FDA for Digital Medicine Device May 23, 2017 The FDA requested additional information, including further human factors investigations. Read More
Ophtec Wins CE Mark for Precizon Presbyopic May 19, 2017 The misalignment tolerance reduces photic phenomena to assist patients in adapting to their vision. Read More
XpandOrtho Gains FDA Clearance for Its Electronic Soft Tissue Balancing Instrument May 18, 2017 The instrument uses a constant pressure bellows system. Read More
CE Mark Suspended on GI Dynamics’ EndoBarrier May 18, 2017 All implanted patients may continue treatment. Read More
FDA Clears New Indication for Myoscience's Iovera System May 18, 2017 Patients treated with the iovera device reported statistically significant greater reduction in pain in the study. Read More
BrainCool AB Achieves FDA Clearance for IQool System for Temperature Management May 17, 2017 The technology platform both cools and warms patients using focused anatomical zones. Read More