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
Orthocell Gets Approval for CelGro Trial in Peripheral Nerve Regeneration October 20, 2016 The study is projected to enroll 20 patients at St. John of God Hospital at the end of the year. Read More
CollPlant Gets CE Mark for Vergenix STR for Treatment of Tendinopathy October 19, 2016 The device is made of cross-linked rhCollagen to be combined with a concentrated blood plasma taken from the patient's blood. Read More
Boston Scientific Releases Resolution 360 Clip October 17, 2016 A study revealed that prophylactic clipping can reduce the risk of bleeding from 9.8 percent to 1.7 percent. Read More
Teleflex Achieves FDA Clearance for Arrow Midline with Chlorag+ard Technology October 17, 2016 The catheter is designed to minimize common midline catheter complications. Read More
BTG and Mirada Medical Achieve CE Mark for Simplicit90Y Dosimetry Software in Europe October 14, 2016 This software allows for more standardized and stable dosimetry planning. Read More
Trice Medical Gains FDA Clearance for Mi-Eye 2 October 13, 2016 The device eliminates the need for a MRI. Read More
FDA Grants Lorenz eCTD Contract October 13, 2016 The company will implement its docuBridge, eValidator and Automator solutions. Read More
FDA Approves Spineology’s Interbody Devices with Allograft Bone October 11, 2016 The devices incorporate large graft windows to facilitate healing. Read More
FDA Approves LBT's Automated Plate Assessment System October 10, 2016 The device interprets data for microbiology culture plates after incubation. Read More