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The FDA has granted Pixium Vision Breakthrough Device status for its Prima System, an investigational device for restoring partial vision for people with blindness caused by dry age-related macular degeneration (AMD). Read More
The FDA has approved the first over-the-counter (OTC) naloxone nasal spray — Emergent BioSolutions’ opioid overdose therapy Narcan, 4 mg — and is encouraging other producers to apply for OTC status. Read More
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.