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

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New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products.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.

Newborn Screening Tests Among FDA Classifications

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

Tarver And Makary Emphasize Commitment To At-Home Healthcare Innovations In FDA Podcast

FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.