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The company said it implemented security controls on the BlueSync technology, such as access restrictions to ensure device integrity and end-to-end encryption to protect patients’ health data. Read More
The system is designed for non-invasive retrograde flushing the ventricular catheter with the goal of restoring or increasing cerebrospinal fluid. Read More
The FDA is taking a three-tiered approach to next-generation sequencing oncology with a newly approved tumor profiling assay, the accreditation of the New York Department of Health as an FDA third-party reviewer, and the creation of the Class II regulatory pathway for these devices. Read More