Startups developing implantable brain-computer interfaces face significant regulatory challenges in obtaining FDA approval[2]. Precision Neuroscience has received 510(k) clearance for an electrode array that can be implanted for up to 30 days to map brain activity[1]. The company has tested the implant in 37 patients during clinical trials since June 2023, previously only temporarily to help remove brain tumors[1]. Synchron is developing the Stentrode, which is inserted through blood vessels without open brain surgery, and its COMMAND trial is testing the control of digital devices in six patients with paralysis starting in 2022[2]. Neuralink has implanted the devices in three patients and is planning mass production in 2026 after receiving FDA clearance[1][3]. The main hurdle is to demonstrate that the medical benefits outweigh the risks of open brain surgery in designing clinical trials[2]. Experts recommend lower-risk devices for home use to make FDA approval more likely[2].