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Following the outbreak of infections related to a deadly superbug, the FDA has provided new guidelines to help healthcare facilities ensure their duodenoscopes are cleaned adequately. Read More
The U.S. FDA has extended until Oct. 24 the deadline to submit required labeling and data to the Global Unique Device Identification Database following the discovery of a security vulnerability. Read More
Following more than 5,000 complaints including reports of patient injuries and four deaths, the FDA is taking a second look at the safety and effectiveness of Bayer’s Essure birth control implant. Read More
A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate the root cause failure that led to power morcellators remaining on the market for more than two decades before being slapped with a black box warning last year. Read More
The FDA is cautioning healthcare facilities on the use of the discontinued Symbiq infusion system after the manufacturer and an independent investigator determined that unauthorized users could gain access to the pump through a hospital network. Read More