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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

US FDA Advisory Panel Backs Claret’s Sentinel TAVR Filter

The panelists said the agency should approve the filter, which is used to protect the brain during transcatheter aortic heart-valve replacement surgery, despite ongoing questions about its effectiveness.

Cardiology Advisory Committees

US Supreme Court Sides With Thermo Fisher In Diagnostics Patent Spat

The justices struck down an appeals court ruling that a single device component could count as a “substantial portion” under patent infringement laws.

Legal Issues Intellectual Property

Class I Recall on Zimmer Biomet Shoulder Replacement

The recall involves 3,662 artificial shoulders manufactured between 2008 and 2011, which have a higher fracture risk than depicted in labeling.

Orthopedics Recalls

First TAVR Filter To Reach FDA Panel Will Get Questions On Missed Endpoint

Claret Medical’s Sentinel embolic protection device for transcatheter aortic valve replacement is set to go before US FDA’s Circulatory System Devices Panel on Feb. 23. Trials found the de novo device is safe, but the agency has some concerns that a primary efficacy endpoint was missed.

Cardiology Neurology

Unlocking Legalities: Gorsuch’s Impact May Be Felt On Free Speech, Preemption

Supreme Court Nominee Judge Neil Gorsuch has ruled favoring device companies on preemption, and in support of an inventor in a device patent case. But experts say the impact he would actually have on the court remains to be seen.

Unlocking Legalities Legal Issues

Unusual False-Claims Settlement Cites GMP Issues

A recent Baxter settlement over moldy air filters shows a move for DOJ to enforce manufacturing quality violations as part of its False Claims Act activities.

Compliance Legal Issues
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