Elizabeth Orr
Elizabeth Orr is managing editor of US regulatory and policy for Medtech Insight, which she joined in 2015 as a reporter focused on legal issues. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include FDANews; DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner. A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.
Latest From Elizabeth Orr
Latest Medicare Data Suggests No Heightened Death Risk For Paclitaxel-Coated Devices
A large study of US Medicare patients treated with either drug-coated stents, balloons or other equivalent devices shows a similar morbidity rate in both groups, further contradicting a 2018 literature review that warned of higher death rates in patients treated with paclitaxel-coated devices.
Company Faces False Claims Charges For Disposable Rectal Probe Reuse
The Prometheus Group reportedly told health care providers that they could reuse probes that were part of its pelvic floor therapy system on multiple patients by covering them with a condom or the finger of a rubber glove.
Federal Small Business Research Grant Programs At Risk Of Expiration, AdvaMed Says
The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs will shut down on 30 September if Congress doesn’t act to renew them – but some US senators say the programs are wasteful and may funnel research overseas.
Watchdog Calls On FDA To Set Policy For Use Of Unauthorized Tests In Public Health Emergencies
The US Government Accountability Office reviewed how the FDA reviewed and monitored COVID-19 tests during the pandemic and found room for improvement. One particular concern was the lack of a straightforward policy on when enforcement discretion would be used.
FDA Allows 510(k)s For HIV Diagnostics
The tests are being moved to class II, special controls, after the agency determined that would be enough to ensure device safety and efficacy.
MDUFA V Passed By US House Health Subcommittee
The user fee package was among several health-related bills that the subcommittee took up on Wednesday.