The federal safety watchdog denied approval for Sedasys back in 2008, prompting J&J to take another run at a PMA, which was also denied. After a rare appeal of that denial in March 2010, the FDA in May 2013 finally approved the device, which is designed to automate mild to moderate sedation during endoscopy procedures.
Sales were modest after a limited rollout and only a handful of providers adopted the system, according to news reports. That led to the decision to abandon Sedasys as part of a larger reorganization at the world’s largest medical device business.
“In line with our strategy to further prioritize our investments in high-growth and strategic portfolio opportunities, our Ethicon franchise has made the decision to exit the Sedasys business,” spokeswoman Kristen Wallace told Outpatient Surgery.
“We have determined it is not a priority growth business for us,” an unnamed Ethicon spokeswoman added in the Wall Street Journal, noting that “there were no safety concerns” involved with the decision and that Ethicon is working with customers on “next steps.”
New Brunswick, N.J-based J&J said in January that it plans to cut as many as 3,000 jobs from its medtech operation, meaning layoffs for about 2.5% of its 270,000-employee workforce, or 4% to 6% of the 60,000-worker medtech headcount. The company said its consumer medical device, vision care and diabetes businesses are not affected.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.