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
Digital Health Review Founder Blair Hirst Focuses On Health Equity
As a biomedical engineer, Blair Hirst saw how health technology could help patients – and how some communities were slowest to benefit. As founder of the Digital Health Review, she now works to improve equity in health care spaces.
News We’re Watching: UK Plans Digital Health Guidance, FDA Warns Against Getinge/Marquet Cardiac Devices
This week, MHRA and NICE released results from their first survey of potential digital health tool users; the FDA warned against using Getinge/Marquet cardiac devices; and Illumina announced plans to hand its Grail spin-off to existing shareholders.
Apple Watch Feature Qualified As FDA Device Development Tool
The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.
Recalls Round-Up: Class 1s For BioMérieux, Fresenius, Draeger, More
A spate of recalls released in recent days follow problems with antibiotic test kits, dialysis tubing, an anesthesia system and infusion pumps. About 4,000 complaints have been reported tied to the recalls.
News We're Watching: LDT Final Rule Near Publication, Zimmer ROSA Used In Shoulder Surgery, $60M For Menopause Clinic
This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer Biomet announced that its ROSA surgical robot had been used in shoulder replacement surgery for the first time; and a virtual menopause clinic closed out a $60M fundraising round.
Epitel Gets 510(k) Clearance On Remote EEG Technology
The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.