Hologic receives FDA warning letter over Biozorb implantable markers
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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FDA warns Hologic to do more to prevent harm from component in recalled implant markers
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...
Marlborough device maker receives FDA warning regarding implantable devices
Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...
FDA Warns Hologic Over BioZorb Manufacturing Violations
FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...
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Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...
Seeking Alpha1mon
Hologic recalls BioZorb Marker over safety concerns
Hologic (NASDAQ:HOLX) has recalled its implantable BioZorb and BioZorb LP Markers over concerns that they can cause irritation, infection and other health complications. The FDA said the devices ...
Nasdaq11d
Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...
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Hologic recalls BioZorb Marker over safety concerns
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 ...