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The Maine-based company, which makes defibrillators, ventilators, and other medical devices, failed to establish and maintain procedures for corrective and preventive action (CAPA), according to the agency

I was sent a treatment proposal, which had only my first name on it, no doctor's name or signature

For example, alpha therapy shows potential in eradicating minimal residual disease (MRD), which is crucial before stem cell transplants to improve patient outcomes