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Masimo’s Opioid Halo system — the first FDA-authorized monitoring solution for detecting opioid-induced respiratory depression — has been granted a De Novo authorization for sale over the counter and by prescription. Read More
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