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 ...

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 U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...

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 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 ...

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.

Also, BioZorb 3D Bioabsorbable Markers were withdrawn from the market following reports of serious adverse events occurring in patients who had the devices implanted in breast tissue.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

HOLX touched a new yearly low this week, reflecting market reaction to its mixed Q1 fiscal 2025 results. Still, the stock offers strong rebound potential.

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 ...