There has been a long PMA drought in orthopedics. This drought has been caused 100% by the FDA, not the device company innovators.
The Most Recent Example.
The first orthopedic panel meeting since 2018 was held with Active Implants. The purpose of the panel meeting was to review the NuSurface clinical data.
The Background. Active Implants sells a total meniscus replacement, called NuSurface, in Europe. I know a bit about NuSurface, because I worked there in R&D.
With a simple outpatient procedure, these lucky Europeans get an new medial meniscus and get their mobility and pain-free ...