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. 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.
FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...
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 ...
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Hologic recalls BioZorb Marker over safety concernsHologic: 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 ...
The U.S. Food & Drug Administration sent a warning letter to Frontier Biologics in November, outlining concerns about the company’s operations. But Frontier Biologics chief scientist Gene ...
Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.
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