There are a lot of factors going into an approval — a couple that may be relevant here:
(i) Synchron had clinical (in human) results from Australia before submitting to the FDA.
(ii) Synchron’s underlying mechanical device is a stent. A million Americans per year get a stent installed, so there is a lot of existing data demonstrating the safety of stents.
(iii) the procedure is basically a typical stent installation and less risky in many ways than open brain surgery. Notably Neuralink built a surgical robot to aid in the installation of their implant but that is yet another product that needs to be approved. Thus, I’d imagine Neuralink’s submission is vastly more complicated.
(i) Synchron had clinical (in human) results from Australia before submitting to the FDA.
(ii) Synchron’s underlying mechanical device is a stent. A million Americans per year get a stent installed, so there is a lot of existing data demonstrating the safety of stents.
(iii) the procedure is basically a typical stent installation and less risky in many ways than open brain surgery. Notably Neuralink built a surgical robot to aid in the installation of their implant but that is yet another product that needs to be approved. Thus, I’d imagine Neuralink’s submission is vastly more complicated.