3 ms·
Still don't understand how this company got FDA approval before Neuralink.
by pelorat 4y ago
Still don't understand how this company got FDA approval before Neuralink.
- Pigalowda 4y agoIs it FDA approved? I thought it was Australian?
- thelastquestion 4y agoYes, they have IDE approval in the US for a clinical trial, after first conducting a trial in Australia.
- thelastquestion 4y agoThere 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.