Elizabeth leads a team of Medtech Insight reporters devoted to covering medical device and diagnostics regulation in the US and abroad. As a reporter, she focuses on FDA regulation, legislation, and legal issues. A graduate of the University of Maryland College Park, she worked for outlets including FDA News, DecisionHealth (formerly UCG) and the Washington Examiner before joining Medtech Insight in 2015. She lives in Arlington, VA, with her husband and children.
Latest from Elizabeth Orr
A major vendor is suing Medicare over new reimbursement policies for skin cancer radiotherapy, which they claim could harm patient access to treatment. The policy applies the same reimbursement level to different equipment types, leading to industry disagreements about whether it’s fit for purpose.
The FDA approved JenaValve’s Trilogy HeartValve for treating severe aortic regurgitation, marking it as the first TAVR device for this condition in the US. The approval, which followed promising clinical results, is significant for patients with limited options due to high surgical risks.
A recent FDA report to Congress reflects ongoing safety issues with orthopedic and cardiac implants, as well as commodities such as syringes and PPE.
A new final guidance document from the US FDA lays out premarket considerations for devices intended to help treat obesity, including clinical trial design, labeling, and safety concerns. The guidance also calls for sponsors to consider patient perceptions in evaluating device effectiveness.
The US FDA's new AEMS database included adverse event reports for drugs and vaccines on March 11, while device, human food and tobacco product data will be added in May.
The US FDA is replacing its individual product type adverse event reporting portals with a unified database, known as AEMS. While adverse event reports for some sectors such as drugs and vaccines joined the new portal on March 11, devices, human foods and tobacco products will be added in May.