Elizabeth Orr

Arlington

Managing Editor, Policy and Regulatory at Pharma Intelligence

Managing Editor, Policy and Regulatory at Medtech Insight

Managing editor of policy & regulation for @Medtech_Insight at @pharma_intell. Any opinions are my own; RTs do not equal endorsement.

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Articles

What’s A Diagnostic? WHO Wants To Know

2 days ago | insights.citeline.com | Elizabeth Orr

What’s A Diagnostic? WHO Wants To Know13 May 2025The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.
First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

3 days ago | insights.citeline.com | Elizabeth Orr

First At-Home Cervical Cancer Screening Tool Gets FDA ClearanceThe US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after. Teal Health’s Teal Wand self-collection device for at-home cervical cancer screening (Nicole Morrison/Teal Health)
AI Rollout Aims To Accelerate FDA’s Product Review Process

6 days ago | insights.citeline.com | Elizabeth Orr

AI Rollout Aims To Accelerate FDA’s Product Review ProcessThe FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration. (Rob Hyrons/Shutterstock)
FDA Announces Classifications On 8 Device Types

1 week ago | insights.citeline.com | Elizabeth Orr

FDA Announces Classifications On 8 Device TypesThe US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector. (Patpitchaya/Shutterstock)
State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

1 week ago | insights.citeline.com | Elizabeth Orr

State And International Enforcement Agencies May Step Up Amid Uncertain Federal EnvironmentStates and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

1 week ago | insights.citeline.com | Elizabeth Orr

FDA And Boston Scientific Face Legal Action Over Spinal Device SafetyA patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.
New Treatment For Chronic Facial Pain Could Launch By Fall 2025

1 week ago | insights.citeline.com | Elizabeth Orr

New Treatment For Chronic Facial Pain Could Launch By Fall 2025NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.
South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

2 weeks ago | insights.citeline.com | Elizabeth Orr

South Korea Adds Digital Health Rules To Already Complicated Regulatory LandscapeA New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
US FDA Commissioner Rejected Some Proposed Reorg Plans

2 weeks ago | insights.citeline.com | Elizabeth Orr

US FDA Commissioner Rejected Some Proposed Reorg Plans FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale. Makary said in an interview that employee morale already had been damaged by rivalries between centers.
No FDA Reorg Planned, Makary Says

2 weeks ago | insights.citeline.com | Elizabeth Orr

No FDA Reorg Planned, Makary SaysFDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.