Somahlution Reveals Positive Study Results Showing Efficacy of DuraGraft October 4, 2016 Treatment to 2,436 patients has shown significant lower risks for adverse cardiac events. Read More
FDA Should Include More Factors in Risk Calculations, Groups Comment October 4, 2016 Recommendations based on absence of actual injuries or deaths may lead to misclassification. Read More
DSM Presents 3C Technology to Bolster Omega-3 Supplements October 3, 2016 The 3C technology delivers concentrated and customizable combinations of EPA and DHA. Read More
Elixirgen Launches Neuron Differentiation Kit October 3, 2016 The device promotes rapid and efficient production of skeletal muscle cells. Read More
FDA Grants Approval to Medtronic’s Artificial Pancreas October 3, 2016 The device system is indicated for patients with type 1 diabetes who are 14 years of age and older. Read More
First Heart Valve That Facilitates Cardiovascular Restoration Implanted in Three Pediatric Patients October 3, 2016 The patients have been enrolled in the “Xplore-I” clinical study. Read More
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