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
Increased demand tied to COVID-19, plus supply chain difficulties, led to the blood collection device shortage, the US agency says.
The US FDA needs enhanced authorities as well as increased funding to track and prevent device shortages, acting commissioner Janet Woodcock argues.
Despite insisting that he would never want to relive the stressful days of 2020, US FDA device center chief Jeff Shuren said the pandemic nevertheless led to improvements in regulatory flexibility and communication with industry.
In this week’s podcast, EU regulatory editor Amanda Maxwell walks us through the latest news and documents coming out of the European Union’s efforts to revamp its medical device and diagnostics rules and makes some predictions about what we can expect to see going forward.
The FDA said the benefits of the devices, which are used to prevent spinal deformity in children with thoracic insufficiency syndrome, outweigh their known risks.
The Texas-based owner-operators of two durable medical equipment companies reportedly submitted about $59m to Medicare in false claims for braces and other equipment.