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 Hologic Inc. over concerns it hasn't done enough to prevent harm from a ...

Get Wall Street's Hottest Chart Every Morning The letter ... Also Read: Hologic Recalls Soft Tissue Marker Device BioZorb, FDA Issues Warning After Almost 400 Complaints Key violations included ...

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.

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 ...

The warning letter follows an FDA inspection of Hologic’s Marlborough, Massachusetts, headquarters between July 30, 2024, and Sept. 24, 2024. The FDA raised concerns that Biozorb’s device design did ...

French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham.

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...