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 ...
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 ...
Also, BioZorb 3D Bioabsorbable Markers were withdrawn from the market following reports of serious adverse events occurring in patients who had the devices implanted in breast tissue.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 ...
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