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
The US FDA has published warning letters to device firms Integra and Hologic. Both letters recount quality systems issues, with Integra’s centering on sterility while Hologic’s addresses a delay in noting safety signals from the company’s recalled BioZorb markers.
While the US FDA will not require diversity action plans for clinical trials for a while, some companies are already sending them in, a new FDA report to Congress shows.
The FDA's new draft guidance for pulse oximeters requires developers to demonstrate device effectiveness across diverse skin tones to address accuracy issues, especially for people with darker skin. The guidance includes clinical study requirements, labeling changes, and recommendations for comparing new devices to predicates.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.
Our dozen-plus experts from across the medtech sector agreed that 2024 was the year when AI went mainstream. They expect it to continue shaping the sector into 2025 and also hope for increased international harmonization, a more business-friendly US government, and increased investment.
From regulations to technology to market dynamics, 2024 was a year of change for the device sector. We asked 14 experts from industry, regulators and other stakeholders to tell us which changes were welcome, and which they’d like to leave in the past.