Medical device research and advisory firm MCRA has had a role in more than half of all orthopedic de novos issued by the FDA.
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.