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 ...

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 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 ...

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.

Get Pro-Level Earnings Insights Before the Market Moves The letter ... Also Read: Hologic Recalls Soft Tissue Marker Device BioZorb, FDA Issues Warning After Almost 400 Complaints Key violations ...

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.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...

Hologic: Continued Room Amidst Bolt-On M&A Efforts Hologic GAAP EPS of $1.01 beats by $0.18, revenue of $987.9M beats by $11.21M Hologic Q3 2024 Earnings Preview Seeking Alpha’s Quant Rating on ...

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