FDA In Safety Communication Says Do Not Use BioZorb Marker Implantable Radiographic Marker Devices; Hologic Recall Due To Reports Of Serious Adverse Events Occurring In Patients Who Had BioZorb Marker Devices Implanted In Breast Tissue
Portfolio Pulse from Benzinga Newsdesk
The FDA has issued a safety communication advising against the use of BioZorb Marker devices by Hologic Inc. due to reports of serious adverse events in patients. Hologic has initiated a voluntary recall of all unused BioZorb Markers. The FDA emphasizes that these devices are not approved for certain uses, such as radiation treatment markers, and advises healthcare providers to monitor patients with these implants.
October 25, 2024 | 5:13 pm
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
Hologic Inc. is recalling all unused BioZorb Marker devices following FDA warnings about serious adverse events in patients. This recall could impact Hologic's reputation and financial performance in the short term.
The FDA's safety communication and Hologic's recall of BioZorb Markers due to serious adverse events are likely to negatively impact Hologic's stock in the short term. The recall could affect the company's reputation and lead to financial implications, as the devices are pulled from the market and potential legal liabilities arise.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100