Arterys Receives 510(k) Clearance for Arterys Software November 3, 2016 The software will be used in clinical settings for the quantification of cardiac flow. Read More
Health Canada Approves Edwards Intuity Heart Valve November 2, 2016 The device is designed to create more time during the treatment of complex heart failure cases. Read More
FDA Grants E-QURE Approval to Initiate Clinical Trial November 2, 2016 The company was approved based as a precondition to initiating the clinical trial on the first 10 patients. Read More
Neural Analytics Receives 510(k) Clearance for Transcranial Ultrasound System November 1, 2016 The device system is a battery-operated medical-grade tablet. Read More
Tyto Care Receives FDA Clearance November 1, 2016 TytoCare’s modular exam tools and telehealth platform enable a remote examination. Read More
Onkos Surgical Receives FDA 510(k) Clearance for Eleos Limb Salvage System October 31, 2016 The Eleos system is a long-term reconstructive option for oncology patients. Read More
FDA Approves IDE for Balloon Angioplasty Clinical Study October 31, 2016 The study is designed to enroll 232 subjects at up to a total of 50 U.S. and international sites. Read More
Corindus Vascular Robotics Gains FDA Clearance for Next Generation Robotic System October 28, 2016 This generation enables control of the guide catheter along with robotic control of the guidewire and balloon. Read More
Senseonics Submits Eversense Continuous Glucose Monitoring system PMA to FDA October 28, 2016 The application hinges on the pivotal trial results. Read More
FDA Clears Vitros Automation Solutions from Ortho Clinical Diagnostics October 28, 2016 The device system is now available for purchase in the U.S. Read More
FDA Approves St. Jude Device for Prevention of Recurrent Strokes October 28, 2016 The study found a 50 percent reduction in the rate of new strokes in participants using the device. Read More
BioTrace Medical Achieves FDA Clearance of Temporary Pacing Technology October 27, 2016 BioTrace Medical has received FDA 510(k) clearance for the company’s Tempo Lead. Read More