Nevro Corp. has submitted a premarket approval supplement to the U.S. FDA seeking a green light for its Senza system to treat chronic pain associated with painful diabetic neuropathy (PDN). This submission is expected to allow the company to gain approval and kick off U.S. launch activities for this indication in the second half of next year. Nevro would be tapping into a big market, as diabetes affects roughly 1 in 10 adults in the U.S. and can damage peripheral nerves, resulting in severe pain and numbness in the extremities.
The FDA has posted the names of the companies that will take part in the ethylene oxide (EtO) challenge in response to the recent state action against EtO device sterilization sites, but the agency also has opened a pilot program for a streamlined notification process for changes to sterilization that should be faster and leaner than the usual PMA supplement.