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
Manufacturers of devices and apps focused on reproductive health are still feeling out the import of a recent US Supreme Court decision overturning the federal right to abortion. Some attorneys say the ramifications may be vast.
For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component
Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.
US regulators plan to hold a public meeting later this year to address concerns the devices are less accurate for people with darker skin tones.
Some defective devices with potential obstructions were mistakenly distributed to clients instead of being destroyed.
A new US FDA draft guidance explains what the agency wants to see in submissions for the devices, which are used to contain potentially cancerous tissue during laparoscopic surgery. Strength, permeability and leakage testing are all key considerations.
US FDA user fees took another step toward renewal Tuesday as the Senate’s Committee on Health, Education, Labor and Pensions (HELP) voted to support the bill along with other health-related issues.