Limitations in the FDA’s adverse event reporting system for medical devices helped allow the widespread use of laparoscopic power morcellators for years before the risk that they can spread cancer became known, a government watchdog said this week. Medical device manufacturers and importers are required to tell the FDA about any device-related adverse events within 30 days. “FDA […]
U.S. Government Accountability Office (GAO)
Report: Feds to investigate power morcellators
The Government Accountability Office said last week it will investigate potential safety and regulatory issues with laproscopic power morcellators, according to The Wall Street Journal. The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove uterine fibroids in women. However, if the device is used […]
GAO: Medtech’s profits jumped 44% in a decade
Profits for medical device companies rose 44% between 2004 and 2014 on 43% sales growth, according to the U.S. Government Accountability Office, which tallied the results from 102 medtech firms at the request of Senate minority leader Harry Reid (D-Nev.). Profits for the companies included in the report (which excluded firms like Johnson & Johnson […]