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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.