An interesting analysis from MedCityNews and Mass Device:
Despite the frequent complaints about the U.S. Food and Drug Administration taking longer to approve medical devices, the agency actually cleared 13 percent more cardiology devices last year than in 2008.
"If there are industries that have good reason to sweat, it's orthopedics and surgical instruments. 510(k )approvals for orthopedic devices fell nearly 14 percent last year and 10 percent for surgical devices. It took the FDA 21 more days to clear an orthopedic device (120 days vs. 99 days) and six more days to green light a surgical device (118 days vs. 112 days)," MedCityNews writes.
MedCityNews says the FDA has tightened scrutiny of orthopedic devices following a scandal around ReGen Biologics' knee cartilage implants.
Read the entire MedCityNews report here.