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Elizabeth Orr

Senior Reporter

About Elizabeth

Virginia, USA

+6 year(s) experience

Elizabeth reports on the medical device and diagnostics industry for Medtech Insight. She focuses on legal issues such as enforcement and intellectual property, but also covers device policy and regulation in the US and abroad.

Elizabeth decided to be a reporter after watching Lois Lane in the Superman movies, and she's never looked back. After graduating from the University of Maryland's acclaimed College of Journalism, she began writing for the healthcare industry as a reporter/editor in DecisionHealth's home health newsletter division. She then worked for employers including the Society of Interventional Radiologists and the Washington Examiner before landing at FDA News, where she wrote and edited Devices & Diagnostics Letter for three years before moving to Informa in 2015. She lives in Arlington, Va., with her kids and her own personal Clark Kent.

Specialties

Policy & Regulation
Medtech
Biotech
Diagnostics
Medical Devices

Elizabeth writes For

Medtech Insight: global medical technology news & analysis

Medtech Insight

US Treasury: Devices To Fight COVID-19 Can Be Shipped To Sanctioned Nations Under New Directive

By Elizabeth Orr 22 Jun 2021

The exemptions allow for face masks, diagnostics and oxygen tanks, among others, to be shipped to Iran, Syria and Venezuela without specific permission.

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Medtech Insight

StrataGraft Topical Burn Treatment Gets US FDA Approval

By Elizabeth Orr 15 Jun 2021

The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.

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Medtech Insight

Doctor At Center Of Medtronic Meal Kickback Scheme To Pay $4.4M Settlement

By Elizabeth Orr 04 May 2021

The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.

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Medtech Insight

COVID-19: New And Updated EUA Templates Focus On Serology Tests

By Elizabeth Orr 17 Mar 2021

The US FDA issued a new template for serology test-makers that detect or correlate to neutralizing antibodies, and also updated an existing template to reflect concerns over viral mutations

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Medtech Insight

FDA Clears CDC Diagnostic For COVID-19 And Influenza

By Elizabeth Orr 27 Nov 2020

The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.

Topic Coronavirus Diagnostics In Vitro Diagnostics Regulation

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Medtech Insight

FDA Boosts Development Of OTC COVID-19 Tests With New Template

By Elizabeth Orr 27 Nov 2020

A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.

Topic Coronavirus FDA Diagnostics

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Medtech Insight

COVID-19: CDRH Staff Leaves Door Open For Some LDT Safety Oversight

By Elizabeth Orr 27 Nov 2020

US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.

Topic Coronavirus FDA

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Medtech Insight

Cepheid Nabs First FDA Authorization For Rapid-Response COVID-19 Test

By Elizabeth Orr 27 Nov 2020

A rapid-response test from Danaher business unit Cepheid will be the first quick COVID-19 diagnostic to reach the US market, the US FDA announced on 21 March.

Topic Coronavirus Medtech

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Pink Sheet

US Election 2020: Trump's Sway Over Courts Expected To Linger

By Elizabeth Orr 09 Oct 2020

Textualist judges appointed by President Trump during his term may block a potential President Biden’s attempts to shift the government’s legal policies.

Topic US Election 2020 Policy & Regulation

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Medtech Insight

FDA Releases New Tools to Speed COVID-19 Test Development

By Elizabeth Orr 05 Jun 2020

The US agency on 29 May gave two additional tools to COVID-19 test developers: an emergency use authorization template for tests using at-home sample collection kits, and a reference panel for the disease.

Topic Coronavirus

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Medtech Insight

COVID-19: FDA Webinar Highlights Developer Challenges

By Elizabeth Orr 12 Mar 2020

A recent US FDA webinar offered insights on the technical challenges developers face in trying to get COVID-19 diagnostics to US patients.

Topic Coronavirus

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Medtech Insight

FDA Proposes End To Quarterly Reporting On HDE, PMA Decisions

By Elizabeth Orr 18 Dec 2019

A proposal from the US FDA would end quarterly publication of PMA and Humanitarian Device Exemption verdicts in the Federal Register. The agency says the practice is inefficient and duplicates online publication.

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Medtech Insight

CooperVision Nabs Approval On Pediatric Contact Lens

By Elizabeth Orr 20 Nov 2019

A newly approved contact lens from CooperVision promises to slow the progression of nearsightedness when prescribed to children aged 8 to 12.

Topic FDA

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Medtech Insight

Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive

By Elizabeth Orr 02 Jul 2019

Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.

Topic Medtech

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Medtech Insight

4C Medical Plans First Early Feasibility Study For An Implantable In Japan

By Elizabeth Orr 07 Mar 2019

4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.

Topic Medtech

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