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.

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even ...

FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...

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 ...

Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...

On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide ...

Piero Cingari Hologic Recalls Soft Tissue Marker Device BioZorb, FDA Issues Warning After Almost 400 Complaints FDA and Hologic advise health providers to return all unused BioZorb Markers due to ...