Elizabeth Orr

Elizabeth Orr

Managing Editor, Policy & Regulation

Washington, DC

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

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

Dermal Fillers For Décolletage May Gain FDA Approval

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.