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The FDA has given Class I designation, the highest level of risk, to Avanos Medical’s March 21 recall of its Cortrak*2 enteral access system because of the potential for serious patient injury or death if the device is misused. Read More
The new assay is the first in a series of planned quantitative assays to support patient care following transplant surgery, the company said. Read More
Virginia-based device manufacturer S. Jackson received a Form 483 for repeat corrective and preventive action (CAPA) and risk analysis deficiencies following a December inspection by the FDA of its Alexandria facility. Read More
Diadem’s AlzoSure Predict blood-based biomarker test for early prediction of Alzheimer's disease (AD) can accurately forecast whether individuals will develop the disease six years prior to a diagnosis, according to research reported in the Journal of Prevention of Alzheimer's Disease. Read More