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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 ...
Medscape6h
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 ...
medtechdive17h
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 ...
drugdeliverybusiness21h
FDA warns of potential missed alerts with smartphone-connected diabetes devices
The FDA today issued an alert around a safety concern regarding diabetes devices that rely on smartphones to deliver critical safety alerts.
Nutrition labels meant to promote healthy eating could discourage purchases
Some food labels designed to nudge Americans toward healthier food choices can have the opposite effect, new University of ...
What is front-of-package food labeling? And will it help?
Earlier this month, the U.S. Food and Drug Administration proposed food companies use new, front-of-package labels highlighting the levels of fat, salt and added sugar in their products.
Acrivon Therapeutics:FDA Grants Breakthrough Device Designation For ACR-368 OncoSignature Assay
The ACR-368-tailored OncoSignature assay is being used to identify patients most likely to respond to the company's lead drug candidate ACR-368 in an ongoing, registrational-intent, phase IIb trial in ...
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.