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
CrossBay Medical Nabs FDA Clearance and CE Mark for IVF Embryo Transfer Catheter Set May 17, 2017 The device is guided by ultrasound. Read More
Smart Meter’s Glucose Monitoring Systems Wins FDA Clearance and CE Mark May 17, 2017 The company expects to launch the product in both markets in 2017. Read More
Oxitone Medical Achieves FDA Clearance for Wrist-Sensor Pulse Oximetry Bracelet May 16, 2017 The device measures critical vital signs such as SpO2 and pulse rate. Read More