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FDA grants breakthrough designation for Acrivon’s endometrial cancer assay
The US Food and Drug Administration (FDA) has granted breakthrough device designation for Acrivon Therapeutics’ ACR-368 ...
Medscape9h
FDA Warns About Diabetes Device Smartphone Alert Settings
The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...
medtechdive19h
FDA labels recall of discontinued Olympus endoscope part as Class I
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of ...
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
FDA labels recall of discontinued Olympus endoscope accessory as Class I
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of the device.
Opinion: The FDA’s new, same-old food labels demand better obesity solutions
All things considered, it’s at least as likely to make health outcomes worse as it is to make most people healthier.
JD Supra9d
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
medtechdive9d
FDA webpages on clinical trial diversity removed after Trump orders
The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...
Yahoo News14d
Opinion | Trump is labeling drug cartels as terrorist groups. That’s a terrible idea.
On his first day in office, President Donald Trump designated drug cartels as terrorist organizations. The executive order fuses the “war on drugs” with the “war on terror,” expanding the legal tools ...
Mexico defends sovereignty as US seeks to label cartels as terrorists
The order did not list any Mexican cartels by name but said Cabinet secretaries would recommend groups for designation as terrorist organizations in the next 14 days.
CBS News21d
How food brands and drugmakers are responding to FDA's ban of food dye Red 3
The best way to check if a product has the dye is to read the label printed on the package. The FDA requires companies to disclose when they use color additives in their ingredients list.