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
News We’re Watching: $1B Judgement Against J&J; Recalls For Abbott, Baxter, More; Karl Storz Announces Fujifilm Partnership
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
Abbott Launches Trial Of DBS Depression Treatment
The DBS trial will look at the use of neurostimulation in people with treatment-resistant depression, which affects about 2.8 million Americans each year. The implanted device may relieve depression symptoms by changing activity patterns in the brain.
Exact Sciences Looks Ahead As Cologuard Marks 10th Anniversary
Exact Sciences’ Cologuard at-home colorectal cancer screening test was the first of its kind when it was introduced to the US market in 2014. What’s ahead for the company as its flagship product moves into its second decade? Medical director Paul Limburg spoke to Medtech Insight about the potential of home cancer screening.
Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Immersive Gaming; DHCoE AI Framework; Hello Heart
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
FDA Announces Four New Device Classifications
The devices include a digital therapeutic to treat ADHD and a tongue muscle stimulator to prevent sleep apnea and snoring. They all initially reached market via the de novo process and have now been declared class II.
News We’re Watching: Regulatory Clearances For Illumina, GE, Boston Scientific; FDA Patient Group To Meet In October; Johns Hopkins Joins AI Accelerator
This week, Illumina announced its new CDx has FDA approval; GE and Boston Scientific nabbed CE marks; and the FDA’s Patient Engagement Advisory Committee announced that its October meeting will focus on informed consent in clinical trials.