Irene Bacalocostantis is a Biomedical Engineer working for the U.S. Food and Drug Administration (FDA). She serves as a Pre-Market Medical Device Reviewer within the FDA’s Center for Devices and Radiological Health, Office of Device Evaluation. Her work largely focuses on reviewing the safety and efficacy of medical devices within the area of gastroenterology. Her areas of concentration include obesity devices, capsule endoscopes, and safer connectors for feeding tubes. In addition to her review work, Irene is involved in several working groups intended to develop internal policies and guidelines to assess the safety and mitigate the risk of these devices.
This interview is part of the American Institute for Medical and Biological Engineering's website initiative for STEM education: Navigate the Circuit (navigate.aimbe.org)