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.

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 ...

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 ...

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

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 ...

Marlborough-based medical device manufacturer Hologic has been issued a warning letter from the U.S. Food and Drug Administration concerning its BioZorb Marker, a device originally recalled in March.

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 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 ...