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Philips Respironics has informed the FDA of two new potential issues with its reworked Trilogy ventilators that were part of a June 2021 recall. Read More
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