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

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.

The letter, addressed to CEO and ... implantable radiographic marker. Also Read: Hologic Recalls Soft Tissue Marker Device BioZorb, FDA Issues Warning After Almost 400 Complaints Key violations ...

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 ...

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 ...

As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or ...