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Under a new FDA rule, medical device manufacturers can add or strengthen contraindications, warnings, precautions or adverse reactions sections of labeling via a premarket application supplement without prior FDA approval, when “such modifications are...
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Investigators, institutional review boards and device trial sponsors can distinguish humanitarian device exemptions from investigational device exemptions by consulting a new draft guidance from the Centers for Devices and Radiological Health. The agency...
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The FDA Monday issued a preliminary public health notification, stating that x-rays used during CT exams may cause some implanted and external electronic medical devices to malfunction. The agency also provided recommendations to reduce the potential...
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