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The FDA investigator noted that the required validations of media fills, stability, equipment, clean room and processes were either not being done or were inadequate. Read More
The letter urges the leaders to adopt the EU’s new regulations covering medical devices and IVDs to encourage global harmonization and to keep EU-wide networks strong. Read More
The Impella RP heart pumpis the only percutaneous temporary ventricular support device for treating acute right heart failure that has received FDA approval. Read More
The potential benefits of MPOCTs include improved patient health care and management, more appropriate use of antibiotics, limiting the spread of disease and cost savings. Read More