FDA to Begin ORA Reorganization in Mid-May April 6, 2017 The current five-region structure will be replaced with six program areas. Read More
New EU MDR Presents Major Compliance Hurdles April 6, 2017 Some devices will have to be reclassified under the MDR’s new classification rules. Read More
Occlutech Obtains CE Mark for its PmVSD Occluder April 5, 2017 The device consists of a flexible nitinol wire mesh with "shape-memory" properties. Read More
AirXpanders Receives FDA Clearance for Modified AeroForm Tissue Expander April 5, 2017 AeroForm administers small amounts of carbon dioxide to gradually stretch breast tissue. Read More
Proposal Would Combine FDA Regs for IVDs, Lab-Developed Tests April 5, 2017 The FDA regulates IVDs but does not actively regulate LDTs. Read More
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