BONESUPPORT: FDA decides on De Novo for CERAMENT V - Redeye

The change from a 510k back to its original De Novo pathway is mostly a non-event for the case. While it shifts the timeline slightly for an approval, we argue that it cements BONESUPPORT’s competitive (regulatory-wise) position, as it makes CERAMENT V the predicate device for future potential market entrants.

Länk till analysen i sin helhet: https://www.redeye.se/research/1142120/bonesupport-fda-decides-on-de-novo-for-cerament-v?utm_source=finwire&utm_medium=RSS