Rishell accused the company of negligently designing, manufacturing and marketing the BioZorb device. The device is used to assist in radiation treatment of breast cancer by identifying breast ...

Design and manufacturing flaws in BioZorb devices, inadequate quality controls, and delayed responses to safety complaints. Calls for a comprehensive corrective plan within 15 business days to ...

The BioZorb Marker is an implantable radiographic marker used to mark soft tissues, such as breast tissue, for future medical procedures, according to the FDA. More on Hologic Hologic, Inc. (HOLX ...

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even though the company recalled the devices last year. Hologic Inc. has ...

Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...

based medical technology company Hologic Inc. over concerns it hasn't done enough to prevent harm from a plastic component in the company's Biozorb implantable radiographic markers. Hologic's ...

Piero Cingari FDA Warns Hologic Over BioZorb Manufacturing Violations FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and ...

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