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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
BioVision Technologies, a Boulder, Colo.-based device company, has shut down in the wake of an FDA inspection that observed multiple failures in procedures, controls and documentation. Read More
In a new guidance on ethical issues, the Advanced Medical Technology Association (AdvaMed) advises against letting a device company’s sales department select as trainers if the company aims to implement bona fide training and education programs for healthcare professionals (HCPs). Read More
Medtronic has completed its $1.1 billion acquisition of the ear, nose and throat (ENT) implant manufacturer Intersect ENT, picking up Intersect’s Propel and Sinuva drug-eluting sinus implant product lines and its Menlo Park, Calif., facility. Read More