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Elizabeth Orr

Washington, DC
Elizabeth Orr focuses on legal affairs affecting the medical device industry. Before joining Informa in September 2015, she spent three years spent reporting on all things device-related at FDANews. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner.  A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.
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Latest From Elizabeth Orr

Device Week, 24 January 2020 – Trends In Breakthrough Medical Devices

On this week’s podcast, senior reporter Elizabeth Orr highlights the most exciting medical device technology coming down the pike as part of the US FDA’s Breakthrough Devices Program.

Device Week Review Pathway

Study Links Paclitaxel To Lower-Leg Amputations

New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.

Research & Development Medical Device

ResMed Pays $39.5M To Settle False-Claims Allegations

Sleep apnea treatment company ResMed Corp. will pay $39.5m to settle allegations that it violated the False Claims Act by giving free or discounted goods and services to distributors and health-care providers to encourage the use of the firm’s devices.

Policy Enforcement

Medtronic Faces Surgical Stapler Lawsuits In Minnesota, Texas

Three patients have filed suit against Medtronic in recent weeks alleging they were injured by malfunctioning surgical staplers made by the company. The lawsuits add to recent scrutiny of the device type’s safety.

United States Regulation

Petition Argues FDA Has Overstepped In PGx Regulation

A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness  an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.

Diagnostics Regulation

Essure Update: Almost All Unsold Units Back To Bayer; Postmarket Study Enrollment Complete

The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.

Post Market Regulation & Studies Regulation
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