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
Califf Sees Big Data, Patient Participation Playing Bigger Roles in Device Assessment September 28, 2016 The agencies are interested in getting the best technology to patients earlier. Read More
EU Deliberates Joint Health Technology Assessments September 28, 2016 The pathway to market access is dictated by individual member states. Read More
CE Mark Awarded to NovaBone for Collagen-Based Dental Wound Dressings September 27, 2016 The device products are designed for management of dental wounds. Read More
HHS Releases Final Rule for Clinical Trial Information Reporting September 27, 2016 The final rule increases the requirements for submitting registration and results information. Read More
FDA Labels Magnetic Surgical Instrument Systems as Class II September 27, 2016 Firms that intend to market this type of device must submit a premarket notification. Read More
Dual Antimicrobial-Testing Development Outlined in Guidance September 27, 2016 The FDA guidance describes interactions between devicemakers and drug sponsors for coordinated development. Read More
FDA Grants Clearance to Medtronic’s StealthStation DBS Lead Placement Software September 26, 2016 The software has been used in more than 2.25 million procedures. Read More
Chinese FDA Builds on Medical Device Submission Document Requirements September 26, 2016 Device manufacturers with Class II and III devices will have to include additional copies of registration. Read More