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Printed By


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

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.

News We're Watching Approvals

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.

Regulation User Fees

DeepWell DTx Brings Mental Health To Meta Store

Zengence, the first virtual reality game intended to help reduce stress, became available earlier this summer. We talked to DeepWell DTx founder Ryan Douglas about the road ahead.

Digital Health Commercial

News We’re Watching: Roche Patent Suit, Dental Device Guidance Docs, Edwards Partners With Affluent Med

This week, Roche filed suit against Foresight Diagnostics and Stanford University over patent infringement; the former head of a COVID-19 test company was convicted of securities fraud; and Baxter announced a recall of Life2000 ventilators.

Commercial Regulatory

FDA's LDT Overhaul Should Go Back To Congress, Appropriations Report Says

A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics. 

Legislation Regulation

FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

Regulation FDA
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