Elizabeth Orr is managing editor of US regulatory and policy for Medtech Insight, which she joined in 2015 as a reporter focused on legal issues. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include FDANews; DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner. A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.
Latest From Elizabeth Orr
The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.
The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.
The agency asked consultants Booz Allen Hamilton to evaluate its handling of diagnostic EUAs as a way to prepare for potential future pandemics.
Benjamin Wallfisch, a senior attorney at the Office of the Inspector General in the US Department of Health and Human Services, recently discussed how companies can avoid apparent violations of anti-kickback law while hosting educational programs.
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union. Topics include discussion of ISO 13485, ongoing industry concerns with MDR implementation, and the Eudamed database expansion.
Agency safety communication says needle-free dermal filler “pens” sold OTC on social media could pose a serious risk to consumers. It's aware of serious injuries, including permanent harm to skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.