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
FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot
The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices.
News We're Watching: Change Healthcare Details Breach Scope, CHAI Releases AI Assurance Draft, FDA Partners With Gates Foundation
This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.
Supreme Court Strikes Down Chevron. What’s Next?
A Friday Supreme Court ruling could create uncertainty for the medtech industry by giving judges more latitude to overrule executive-branch decisions. While some pro-business groups applauded the decision, others saw risks as well as benefits.
Experts Say LDT Small-Business Compliance Guide Does Little To Persuade
A new FDA lab-developed test compliance guide for small enterprises summarizes agency policy but fails to address clinical lab industry concerns about the LDT final rule.
Pediatric Orthopedic Device Drought Continues, Study Finds
A recent review of orthopedic device approvals between 2018 and 2022 found that less than 10% of 510(k) devices – and less than 5% of PMA and de novo products – have been authorized for use in children, highlighting the ongoing lack of pediatric devices.
News We’re Watching: Boston Sci Buys Silk Road Medical; EOFlow Injunction Blocked; LDT Compliance Dates Announced
This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.