The FDA has issued a total of 14 orthopedic de novos, eight of which were for clients of MCRA, according to a May 9 press release from the company.
MCRA also had a hand in the first ever orthopedic de novo, granted in 2017 for IlluminOss Medical.
MCRA helps medical device companies with research, compliance, reimbursement, quality insurance and more from conception to commercialization.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
