Clinical trial pathway for BCIs

Most news about BCI companies refers to a stage in the medical-device approval process. Here’s how it works in the United States, which most companies target first.

The main steps

1. Pre-clinical testing: bench, safety and animal studies of materials, electronics and surgery.
2. IDE (Investigational Device Exemption): FDA permission to test an unapproved, significant-risk device in humans.
3. Early feasibility / first-in-human study: a handful of participants (often 1 to 10), focused mainly on safety and whether the device works at all. Neuralink’s PRIME and Synchron’s COMMAND are examples.
4. Pivotal trial: a larger, carefully designed study that gives the main evidence of safety and effectiveness.
5. Marketing authorization: the FDA’s decision. There are three main routes:
   • 510(k) clearance: the device is “substantially equivalent” to one already on the market. Precision’s Layer 7 was cleared this way for temporary use.
   • De Novo: for new, low-to-moderate-risk devices with no predecessor. Neurolutions’ IpsiHand and ONWARD’s ARC-EX took this route.
   • PMA (Premarket Approval): the strictest route, required for high-risk devices such as permanent brain implants.

Speed-ups

The Breakthrough Devices Program gives promising devices for serious conditions more interaction with the FDA and priority review. It doesn’t lower the evidence bar.

After approval

Approval isn’t the finish line. Companies still need insurance coverage (in the US, decisions by the Centers for Medicare & Medicaid Services, CMS), surgeons trained to implant the device, and long-term follow-up studies.

Outside the US

Europe uses CE marking under the Medical Device Regulation (MDR). China, Australia and others have their own processes, and several BCI companies now run trials in multiple countries.