FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...
Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
Also, BioZorb 3D Bioabsorbable Markers were withdrawn from the market following reports of serious adverse events occurring in patients who had the devices implanted in breast tissue. Furthermore ...
The Biozorb devices were implanted in breast tissue to mark tumor excision sites for monitoring or future treatments. They consist of a plastic component intended to dissolve into patients’ bodies and ...
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 ...
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