Elizabeth Orr
Managing Editor, Policy & Regulation
Elizabeth leads a team of Medtech Insight reporters devoted to covering medical device and diagnostics regulation in the US and abroad. As a reporter, she focuses on FDA regulation, legislation, and legal issues. A graduate of the University of Maryland College Park, she worked for outlets including FDA News, DecisionHealth (formerly UCG) and the Washington Examiner before joining Medtech Insight in 2015. She lives in Arlington, VA, with her husband and children.
Latest From Elizabeth Orr
Medtronic Lands Surprise Approval On Symplicity Spyral
The US FDA’s decision to allow Medtronic to market the Symplicity Spyral renal denervation (RDN) device sets up a rivalry in the RDN market, as the medtech giant’s offering will come up against ReCor’s Paradise system.
News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope
This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.
Flowflex Becomes First OTC COVID-19 Antigen Test Cleared Through Substantial Equivalence Pathway
Test is among first of a wave of products initially authorized for emergency use by FDA now pursuing traditional approval pathways to stay on market.
Flowflex Becomes First At-Home COVID-19 Antigen Test Cleared Through 510(k)
The test is among the first of a wave of products initially authorized for emergency use by the US FDA that are now pursuing traditional approval pathways to stay on the market.
Blood Irradiation Devices May Be Class III, FDA Panel Says
The FDA radiological devices advisory panel said that there wasn’t enough evidence backing the use of irradiation to prevent metastasis in the blood of cancer patients, especially given the treatment’s known risks.
FDA Continues Enforcement Discretion On Some Changes To PMA And HDE Devices
The policy allows device developers to change some device materials or manufacturing practices without first alerting the agency, as long as the alterations are a result of manufacturing or supply chain issues.