Redeye comments on Paxman’s FDA process on its CIPN device. The FDA’s recommendation to pursue the De Novo pathway provides clarity on the route to US approval, but also means that the previously expected 2026 launch is likely to be pushed into 2027e. While the update does not affect the European launch planned for Q4 2026, it adds some uncertainty to our CIPN estimates, which we leave unchanged for now until further clarity regarding the updated timeline.
LÄS MER
