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

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

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

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test ReimbursementThe US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.
Congress, Researchers Highlight Security Risks At DNA Testing Services

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

Congress, Researchers Highlight Security Risks At DNA Testing ServicesCongress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices. (Daily Insights/Shutterstock)
Congress, Researchers Highlight Security Risks At DNA Testing Services

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

Congress, Researchers Highlight Security Risks At DNA Testing ServicesCongress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices. (Daily Insights/Shutterstock)
Guidance Comments Highlight Outstanding Questions In AI Development

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

Guidance Comments Highlight Outstanding Questions In AI DevelopmentMany of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.
Medtech Looks For Relief As Trump Hits Pause On Most Tariffs

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

Medtech Looks For Relief As Trump Hits Pause On Most TariffsThe medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk. (Cagkan Sayin/Shutterstock)
IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

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

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And ImplementationInternational device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.
Shuren Expects Longer CDRH Review Times

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

Shuren Expects Longer CDRH Review TimesThe FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems. Screenshot of speakers during a 3 April webinar on the future of the FDA, clockwise from top left: Martin Leon, Jeff Shuren, Juan Granada, Adam Saltman and Kenneth Ouriel. (Citeline)
Medtech Industry Faces Tariffs Despite Pleas for Exemption

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

Medtech Industry Faces Tariffs Despite Pleas for ExemptionMedical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.
First At-Home Test For Multiple STIs Gets FDA Clearance

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

First At-Home Test For Multiple STIs Gets FDA Clearance The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.
Digital Health Roundup: Intuitive Surgical CEO Exec Chat, AI Alert System, FDA, Roche New NGS Prototype

3 weeks ago | insights.citeline.com | Elizabeth Orr |Shubham Singh |Brian Bossetta |Marion Webb