5 points
To an extent, but I think the concern is that there were still documented device failures in live subjects, and if it’s going to start human trials on quadriplegic they are going to have a tough time convincing IRBs, providers, and patients of it just as effective as existing treatments with side effect profile. As there are none, IRBs are going to really push back on the whole “yeah this will explicitly kill people,” instead of like cancer research “the patient will have treatment with nothing worse than standard treatment of care.”
Or, put another way, in the U.S., a quadriplegic receives no treatment and lives, vs a quadriplegic who under goes the implant and dies from the implant (as specified in the article).