Myriad’s BRACAnalysis CDx Test Identifies Patients Who Would Benefit from Olaparib October 26, 2016 The device was included in the SOLO2 study as a diagnostic with olaparib. 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
Cimzia AutoClicks Prefilled Pen Now Available in UK Through NHS October 25, 2016 The monthly cost to the NHS for treating a patient using the certolizumab pegol AutoClicks Prefilled Pen is $776.98. Read More
Veracyte Launches Envisia Genomic Classifier October 25, 2016 The company revealed clinical validity through the BRAVE study results. Read More
Pinnacle Spine Group Launches InFill V2 Lateral Interbody Device October 25, 2016 The device features a larger, single graft chamber. Read More
St. Jude Medical Recalls Cardiac Defibrillators October 25, 2016 Reports of battery failures due to buildups of lithium clusters and short circuits lead to a Class I device recall. Read More
Discontinue Use of Multidata Radiation Therapy Devices, FDA Says October 24, 2016 The FDA is aware of two Multidata medical devices that the company manufactured and distributed in the U.S. 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
HeartWare Issues Recall for Ventricular Assist Device Pumps October 24, 2016 The HVAD assists in delivering blood from the heart to the rest of the body. Read More
TeleFlex Medical Issues Recall for Tracheostomy Tube Set October 24, 2016 Devices were distributed between July 2015 and May 2016. Read More
Vascular Solutions Gains 510(k) Clearance for Fluent Inflation Device October 21, 2016 The design provides a system that is easy to fill, flush, and operate. 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