We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
California’s HeartVista has teamed with Germany-based Siemens Healthineers to co-market an automated cardiac magnetic resonance (CMR) imaging exam platform that takes up less scanner time and requires no additional training for technicians. Read More
The integrity of manufacturers’ data is a major focus of FDA inspections and the agency’s investigators will go to great lengths to uncover problems, three former FDA inspection officials told attendees at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. last week. Read More
Devicemakers need to be prepared to comment as the FDA rolls out guidance related to the incorporation of ISO 13485:2016 into the FDA’s proposed Quality Management System Regulation (QMSR), said a former senior agency official at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. Read More
The latest approval is based on data from a phase 3 trial in which Liletta was about 99 percent effective in preventing pregnancy up to eight years. Read More
The FDA posted a series of frequently asked questions (FAQ) Thursday about the use “legacy” identification numbers for medical devices as the agency shifts to the Unique Device Identification (UDI) system. Read More
Cybersecurity doesn’t just apply to the products you are building today, it applies to legacy products still in use many years after installation — and devicemakers need to install post marketing updates that either bring these older devices up to today’s standards, or make them obsolete, advised one device security expert at the WCG-FDAnews Annual Inspections Summit in Washington, D.C., on Thursday. Read More
Johnson & Johnson (J&J) and its subsidiary Ethicon are seeking a review by the U.S. Supreme Court (SCOTUS) of the $302 million in imposed on them for misrepresenting the risk of their pelvic mesh products in marketing materials, arguing their due process rights were violated. Read More
The approval was based on a clinical trial in which about 35 percent of the 106 enrolled ovarian cancer patients were positive for the marker, as determined by the assay. Read More