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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

J&J To Pay $117M, Resolving Mesh Marketing Suits In 41 States

Johnson & Johnson and subsidiary Ethicon will pay $117m to settle state lawsuits alleging that their marketing misrepresented the safety and risks of transvaginal mesh devices.

Medical Device Commercial

Personalized Medicine Firm Pays $42M On Kickback Allegations Tied To Genetic-Testing Registry

Louisiana-based pharmacogenetic testing company UTC Laboratories and its three principals have agreed to pay $42.6m to resolve allegations that the company violated the False Claims Act by paying kickbacks for referrals and providing tests that were not medically necessary.

Diagnostics Enforcement

German Patient Data Shows No Paclitaxel Mortality Risk

A review of German insurance data found no additional risk of death in patients treated with drug-coated balloons and stents, even in patients who had the devices for more than a decade. The data appears to further challenge a bombshell meta-analysis that claimed paclitaxel could increase death rates by up to 90%.

Germany Medical Device

Device Week, 11 October 2019 – Total Recall: The Latest On Corrections & Removals

On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information.

Device Week Recalls

New Guidewire 510(k) Guidance From FDA Advises On Coating Tests

Newly finalized guidance from the US agency updates its recommendations for 510(k) submissions for guidewires intended for use in coronary vasculature, peripheral vasculature and neurovasculature. The document, which replaces a 1995 guidance, reflects serious risks posed by certain guidewire coatings.

Review Pathway Guidance Documents

Compliance Corner: FDA Officials Share Tips To Ensure A Smooth Recall

Officials in the US FDA's recall divisions advised manufacturers on the best ways to work with the agency during the recalls process, including keeping track of who they're speaking with, making sure all required forms are complete, and not being afraid to use eSubmit.

Compliance Corner Recalls
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