India Proposal Would Set Distinct Standards for Medical Devices October 3, 2016 In the draft document, the regulator proposed third-party certification bodies. Read More
Australia Recalls Rehab Assist’s Carry Bars for C-Series Ceiling Hoists September 30, 2016 Nine incidents of damage to the bar’s plastic swivel have been reported. Read More
Upcoming Rules in Australia to Allow Earlier Access to Medical Devices September 30, 2016 Greater reliance on approval by foreign authorities is proposed. Read More
Guidance Addresses Computational Modeling in Device Submissions September 30, 2016 FDA seeks to pave the way for increased use of computer modeling in device trials. Read More
CDRH Outlines Regulatory Priorities for Fiscal 2017 September 30, 2016 Priorities center on expanded collection of data and new ways to manage it. Read More
Glidewell Launches Line of Dental Bone Grafting Products September 29, 2016 Demand is increasing for bone grafting products for dental implant procedures. Read More
Prospective Trial Shows Precision Medicine Benefits in Cancer Treatment September 29, 2016 33 percent had improved progression-free survival following a comprehensive genomic analysis. Read More
UL White Paper Outlines Steps to Ensure Data Integrity Compliance September 29, 2016 The goal is to enable the FDA to determine how the data are obtained and recorded. Read More
Senators Urge DOJ Probe of EpiPen Generic Classification September 29, 2016 Mylan paid a 13 percent Medicaid rebate rather than the standard 23.1 percent. Read More
Quidel Receives FDA Clearance for Solana(R) Influenza A+B Assay September 28, 2016 The device produces results in under an hour. Read More
FDA Grants Approval to Abbott’s Freestyle Libre Pro System September 28, 2016 The device measures a patient’s glucose levels and patterns. Read More
Infections Linked with Reprocessed Bronchoscopes September 28, 2016 The risk of infection presented by reprocessed bronchoscopes is lower than reprocessed duodenoscopes. Read More