Gaining regulatory approval for a new device in the U.S. is rarely an easy or short process, but for some medical device companies that journey is a heck of a lot longer than anticipated. One company that is all too aware of how difficult the FDA approval process can be is FzioMed (San Luis Obispo, California), which has been trying to get FDA approval for its Oxiplex Gel for 12 years. The company reported this week that the FDA has approved its petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel to be used during lumbar spine surgery. Read More
