An FDA panel is slated to meet next month to evaluate the testing and use of flow diversion technology, the stent-like devices used to treat brain aneurysms.
An FDA advisory panel is slated to meet in April to discuss flow diversion technology – stent-like devices used to treat brain aneurysms – and evaluate how they're designed and tested for human use.
By Mark Vermette, Principal Consultant, Halloran
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
A new report commissioned by the US Food and Drug Administration recommends a seven-year, multi-step implementation project in order to establish a nationwide postmarket surveillance system for medical devices.
Boston Scientific confirms speculation with a $1.65 billion bid for Endo International's urology business, not including its star-crossed American Medical Systems pelvic mesh business.
Corindus Vascular Robotics says it's launching a clinical trial of its CorPath robot-assisted surgery device in treating peripheral artery disease.
Corindus Vascular Robotics said it's launching a 20-patient trial of its CorPath robot-assisted surgery device in treating peripheral artery disease.
The U.S. Securities & Exchange Commission settles civil charges against a banker implicated in the $2 billion accounting scandal that nearly sank Olympus.
Registrar Corp's U.S. FDA News blog provides regulatory updates for FDA regulated industries. Registrar Corp helps medical device establishments comply with FDA regulations, such as registration, listing, UDI and GUDID requirements, 510(k) requirements, and more.
By David Lennarz, Vice President and Co-Founder of Registrar Corp
