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
Medtronic Gets FDA Approval for Aortic Valve Replacement System October 27, 2016 Medtronic has been granted FDA clearance of the CoreValve Evolut R 34 mm valve. Read More
Spineology Aquires FDA Clearance of Rampart Duo Interbody Fusion System October 26, 2016 The device allows for decreased retraction requirements when compared to current interbody systems. Read More
Quidel Receives FDA Clearance for Solana(R) Strep Complete Assay October 26, 2016 The device can process up to 12 patient samples in each 25-minute run. Read More