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Elizabeth Orr

Managing Editor, Policy & Regulation

Washington, DC

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.

Approvals FDA

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This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR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.

Regulation Coronavirus COVID-19

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. 

FDA Coronavirus COVID-19

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. 

Approvals FDA

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.

Advisory Committees FDA

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.

Policy Enforcement
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