New Cancer Center Played Pivotal Role In Endomag's Success
Executive Summary
US FDA's new Oncology Center for Excellence brought in key experts to help review and approve Endomag's new Magtrace and Sentimag System combination product to help surgeons trace and remove breast tumors. The case highlights how disease-specific centers could change the way the agency reviews products, and it also spotlights the agency's recent efforts to improve combination product reviews. Check out our Q&A with FDA's Binita Asher.
You may also be interested in...
FDA Says It's Taking Steps To Simplify Combo Product Consultations
The agency released an internal assessment of how it handles intercenter consultations for combination products. As expected, there are some serious challenges to collaboration between the centers, but FDA says it is taking tangible steps to make it better.
Massive Family Dollar Rat Infestation Leads To Multi-State Recall
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.
Digital Health Roundup: Exec Chats With Illumina, Bloom, AngelMed; M&A, Funding; FDA Down-Classifies Apps
In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.