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 ...

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 ...

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 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 ...

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 ...

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 ...

In January 2025, the U.S. Environmental Protection Agency added 9 PFAS (per- and polyfluoroalkyl substances) chemicals to their Toxics Release Inventory (TRI) list. Certain facilities will be required ...

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 ...