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Alio, a firm focused on wireless remote patient monitoring, has received FDA clearance to add potassium, hematocrit and hemoglobin monitoring to its non-invasive SmartPatch system.
The expanded approval is for patients who are at least 13 years old who cannot be effectively treated with continuous positive airway pressure (CPAP) therapy. Read More
The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device. Read More