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
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