Masimo is one of eight U.S. companies to be selected for the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder. Initially announced in May, this Innovation Challenge is designed to spur the development of medical devices to help combat the opioid crisis and achieve the goal of preventing and treating opioid use disorder. From over 250 applications, 8 medical device developers were selected to participate, including Masimo.In a statement, the FDA noted that “Through this effort, the FDA seeks to provide device developers an opportunity to work directly with the FDA to accelerate the development of innovative products, such as diagnostics to identify patients at increased risk for addiction, non-opioid pain therapies for acute or chronic pain, treatments for opioid use disorder or symptoms of opioid withdrawal, as well as devices that monitor the use and prevent diversion of prescription opioids.” Masimo and the other winners will work directly with the FDA to accelerate the development and review of innovative products, which will be eligible for “Breakthrough Device” designation.
