ConvertX Nabs FDA Clearance for Kidney Stent System November 30, 2016 The device is implanted and converts from a catheter to a stent. Read More
FDA Strengthens Guidance on Quality Agreements with CMOs November 30, 2016 The FDA expanded the elements that should be included in most quality agreements. Read More
Russian Regulators Have Updated Qualifying List of Implantable Medical Devices November 29, 2016 Russian regulators update implantable medical device list. Read More
Final GDUFA Guidance Clarifies Penalties for Unpaid User Fees November 29, 2016 Sponsors that are delinquent on user fees will be charged interest at a rate determined by the Treasury Department. Read More
Konica Minolta Healthcare Reveals AeroDR HD High Resolution Digital Radiography Detector November 28, 2016 The range mode aggregates the data to provide faster processing and more contrast for the anatomical areas. Read More
GAO: FDA Makes Headway on Compounding Regulations, but Progress is Slow November 28, 2016 Drug compounders have lamented the amount of time the agency takes to review industry comments. Read More
Exact Imaging Receives CE Mark Approval for its ExactVu Micro-Ultrasound System November 23, 2016 The system's high resolution derives from its operating frequency of 29 MHz. Read More
Final Rule Modifies Requirements for Medical Gas Containers November 23, 2016 It also modifies the proposed rule to add a warning statement for oxygen labeling. Read More
Spectranetics Wins CE Mark for Smaller Stellarex DCB November 22, 2016 The device is designed to treat small vessels. Read More
ICH Adopts Update to GCP Guideline; Regional Guidances to Follow November 22, 2016 ICH members also agreed to consider renewing the wider package of guidelines. Read More
Industry Attracts India Govt's Focus on Gaps in Medical Device Rules 2016 Draft November 21, 2016 The medical technology industry weighs in on medical device rules 2016 draft. Read More
Supreme Court Declines to Hear Challenge on OxyContin Patent Invalidation November 21, 2016 The high court denied a petition from the branded drugmakers to overturn a lower court ruling. Read More