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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 Trade Groups Offer Lukewarm Comments On Pre-RFD Draft

BIO and AdvaMed offered multiple concerns about a January US FDA draft guidance formalizing the pre-RFD process, including that the timeline is too long and that the recommended information may not land manufacturers a center designation.

Combination Products Review Pathway

Stakeholders Support OTC Hearing Aids At FTC Summit

Most stakeholders speaking and participating in panels during the Federal Trade Commission’s April 18 workshop on hearing aids expressed support for over-the-counter sales of the devices, though several expressed reservations about how to best protect patients.

Ear Regulation

Federal Trade Commission Plans Workshop To Address Hearing-Aid Regulations

The US Federal Trade Commission plans to discuss hearing-aid marketing rules at an April 18 workshop. The workshop joins other recent government efforts, including a Senate bill and a US FDA draft guidance document, to grapple with a 2015 report by the President’s Council of Advisors on Science and Technology that found cost and regulations blocked many patients with hearing loss from getting help.

Ear Regulation

Jury Awards $450m In Class-Action Charging Fraud In Gown Infection-Protection Claims

Halyard Health plans to appeal the verdict, which stems from allegations the company and its former parent, Kimberly-Clark, fraudulently promoted surgical gowns as offering more protection than they really did.

Commercial Legal Issues

FDA Emphasizes Pre-Submissions For Neuro Devices

Make pre-submissions early and as complete as possible to ensure speedy review and thorough answers for neurological devices, FDA staff says.

Neurology Regulation

Fed Circuit: Inventor’s Family Should Pick Up Medtronic Lawyer Fees

The decision is a coda to a 2014 Federal Circuit verdict that an implantable cardioverter defibrillator patent held by Mirowski Family Ventures was invalid. About $6m in attorney’s fees were at stake.

Intellectual Property Cardiovascular
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