The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...

FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...

Enough evidence for jury to consider failure to warn claim Case is one of nearly two dozen Hologic faces over BioZorb Hologic Inc. can’t shake a woman’s suit alleging the medical device manufacturer ...

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...

The court concluded genuine issues of material fact existed regarding whether an advanced warning of the alleged risks of a ...

BioZorb, a medical device manufacturer, could not dodge the majority of the negligence and breach of warranty claims brought ...

The Food and Drug Administration’s recall process was a key topic for the medical device industry in 2024. At the start of the year, the U.S. Government Accountability Office said it would look at the ...

Hologic (NASDAQ:HOLX) has recalled its implantable BioZorb and BioZorb LP Markers over concerns that they can cause irritation, infection and other health complications. The FDA said the devices ...

In the latest string of adverse rulings against gunmaker Sig Sauer, a federal judge in Massachusetts rejected the firearm manufacturer's attempts to discredit a widely contested expert's opinion ...