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
RTI Surgical Gains Additional 510(k) Clearance for Streamline OCT System October 26, 2016 This clearance expands the indication for polyaxial screw placement. Read More
FDA Approves Jarvik Heart Trial for Pediatric Cardiac Assist Device October 24, 2016 The 15mm-diameter device is designed for patients under one year up to about age 10. Read More
Two FDA Clearances for Medicrea New Specialized Components for Pediatric Deformity October 21, 2016 Surgeons will treat pediatric patients using around 40 percent less implant volume in each surgery. Read More