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
This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.
Clinical labs and diagnostics firms alike are still grappling with the likely impact of the FDA’s final rule on LDTs, speakers said in a recent webinar. Key areas of concern: The potential for lab consolidation, lack of clarity on when clearance is necessary, research-use tests, and the hesitation imposed by an ongoing lawsuit and upcoming election.
After more than 20 years in patient care, cardiologist Ethan Korngold became chief medical officer for Abbott’s vascular business in April. How was his first conference on the industry side of the table? “Incredibly invigorating,” he said, offering updates on Abbott’s Ultreon and Esprit BTK product lines.
This week, Medtronic and Hologic announced major safety issues; the US government awarded $110m to innovators in women’s health; CDC partnered with Quest on a bird flu diagnostic; and more.
House Republicans say the FDA has not done enough to support its laboratory safety office, despite past recommendations.
Acting director Michelle Tarver has been named the new permanent director of the US FDA’s Center for Devices and Radiological Health.