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

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

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

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges RemainDuring a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety. (PeopleImages.com/Shutterstock)
Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

3 weeks ago | insights.citeline.com | Marion Webb |Brian Bossetta |Natasha Barrow |Elizabeth Orr

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMapIn this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Zika Virus Test Among 4 New FDA Device Classifications

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

Zika Virus Test Among 4 New FDA Device ClassificationsThe FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel(Jarun Ontakrai/Shutterstock)
FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

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

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy IssuesThe FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

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

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT RulingA Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight. (Andrey Popov/Shutterstock)
Debate On FDA User Fee Reauthorization Begins To Take Shape

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

Debate On FDA User Fee Reauthorization Begins To Take ShapeA battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust. Rep. Jake Auchincloss, D-MA, pictured in front of the Capitol building in 2024.
Kennedy Defends Spending Cuts During Contentious Senate Hearing On HHS Budget

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

Kennedy Defends Spending Cuts During Contentious Senate Hearing On HHS Budget Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs. HHS Secretary Robert F. Kennedy Jr. testifies during a Senate budget hearing on 14 March. (Source: screenshot from YouTube)
Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

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

Health Secretary Defends Spending Cuts During Senate Hearing On HHS BudgetHealth and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
What’s A Diagnostic? WHO Wants To Know

1 month 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

1 month 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)