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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.

Latest From Elizabeth Orr

US High Court Punts On ‘Objective Falsity’ FCA Standard

Can a false-claims suit be filed if doctors have different opinions about whether a treatment was necessary? The Supreme Court won’t say.

Regulation Enforcement

Office Supply Vendor Faces Proposed Class Action Over Counterfeit N95 Masks

The proposed class action suit alleges that W.B. Mason took advantage of the pandemic by overcharging for the phony respirators.

Enforcement Consumer

Recall Of Valiant Navion Could Cost Medtronic $40M

The company ordered the recall after three stent fractures and a death occurred in an 89-participant clinical trial.

Recalls Safety

Pulse Oximeters May Be Less Accurate For Dark-Skinned People, FDA Warns

The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.

OTC Devices Safety

US FDA Eyes March For Submission Tracker Pilot Launch

The program will be open to roughly a hundred device firms with traditional 510(k)s under review between March and May of this year.

Approvals FDA

FDA Panel Votes No On BD's Balloon For Below The Knee

Shifting trial design and missing data, plus little evidence of benefit, worked against the paclitaxel-coated balloon, panelists and US FDA speakers said.

FDA Regulation
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