Shuren Tells Congress FDA Workload Continues to Rise April 5, 2017 The agency needs all the anticipated funding from the latest medical devices user fee agreement. Read More
Milestone Gains Marketing Clearance for Epidural and Intra-Articular Instruments in Australia April 4, 2017 The devices utilize DPS technology. Read More
ETS Wound Care Wins FDA Clearance for Mirragen April 4, 2017 The device is designed to be packed into wounds to manage and control wound fluids. Read More
FDA Reports to Congress on Regulatory Science Achievements April 4, 2017 CDRH researchers developed computational tools to support nonclinical evaluation of medical products. Read More
CDRH Priorities Focus on Data, Quality April 4, 2017 The center has increased staff with quality credentials by 300 percent. Read More
NICO Wins CE Mark for BrainPath Non-Disruptive Cranial Access Technology April 3, 2017 BrainPath is designed to displace brain tissue as it creates a corridor to the tumor or hemorrhage site. Read More
Singulex Gains CE Mark for Sgx Clarity System April 3, 2017 Singulex will submit data for regulatory clearance of the Sgx Clarity system in the United States. Read More
Gottlieb to Recuse Himself from Agency Decisions on More than 20 Companies April 3, 2017 Gottlieb plans to resign from 13 industry roles. Read More
UK’s MHRA Releases New Guidance on ‘Virtual Manufacturing’ April 3, 2017 Previously, notified bodies did not require full QMS audits. Read More
RenovoRX Expands Indications for Use for Dual-Balloon Catheter March 31, 2017 The RenovoRx uses two balloons, which allows for more targeted therapy. Read More
FDA Clears QIAGEN JAK2 Assay March 31, 2017 The JAK2 assay is the first and only FDA-cleared kit for the JAK2 V617F mutation. Read More
FDA Grants UDI Extension for Soft Contact Lenses March 31, 2017 Assigning a different UDI to each prescription would produce a large number of virtually identical records. Read More