Therefore, he is using a device in what the FDA would consider an experimental procedure. Therefore, he cannot do that without FDA approval and without IRB, their research ethics board equivalent, approval, and he was, so that has been shut down.
Or, il ne peut pas faire cela sans l'approbation de la FDA et sans l'approbation de l'IRB, son équivalent du comité d'éthique de la recherche.