Elizabeth Orr
Managing Editor, Policy & Regulation
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
News We’re Watching: Edwards Scoops Up Cardio Firms, BD And Quest Partner, Admera Settles Kickback Case
This week, Edwards announced that it has purchased JenaValve and Endotronix; a New Jersey lab has agreed to pay the government $5m for violating anti-kickback law; eCential Robotics’ spine platform made its debut for human use; and more.
Shuren Steps Down As US FDA Device Center Director
Shuren is retiring after 15 years as head of the FDA Center for Devices and Radiological Health.
BREAKING: Shuren Steps Down As CDRH Director
The US FDA device center head is retiring after 28 years in the federal sector and 15 at the helm of CDRH. Deputy center director Michelle Tarver will step in as acting head.
Court Orders Asset Freeze For Test Strip Counterfeiters
A New York district court ordered the asset freeze after finding that the owners of H&H Wholesale Services had concealed or gambled away money owed to Abbott. The company was ordered to pay Abbott $33m in 2023 for distributing test strips authorized for sale only outside the US.
News We’re Watching: Nipro Medical Invests $397.8M In First US Facility; Baxter, Hamilton Ventilator Recalls; FDA Warnings; And More
This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.
Q&A Guidance Doc Dives Into Combination Product User Fees
The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.