FDA Not Satisfied with Neuralink’s BCI Implants Ambitions: Report

Neuralink’s ambitions to implant brain-computer interface (BCI) in humans have yielded another blow. A new article from Reuters has suggested that the chances of Neuralink bringing a product to market remain unlikely. The FDA (Food and Drug Administration) reportedly denied BCI authorization in 2022 to perform human studies using the same devices that killed the pigs.

Current and former Neuralink employees told Reuters that the FDA was concerned about the lithium battery, the possibility for the implant’s small wires to travel to other areas of the brain, and whether or not the gadget could be withdrawn without injuring brain tissue.

The FDA’s apprehensions concerning the battery system and its new transdermal charging capabilities revolve around the device’s chances of failure. According to Reuters, the FDA is requesting evidence that the battery is “very unlikely to fail” since the release of electrical current or heat energy from a ruptured pack could cause tissue damage.

Due to the minute size of the electrical leads that extend into the patient’s grey matter, the FDA is also concerned about potential complications in the event that the entire device must be removed, whether for replacement or update. These leads are so small and fragile that they risk breaking off during removal (or even during normal use) and migrating to other regions of the brain, where they could become lodged in something vital.

Musk asserted confidently during November’s open house for Neuralink that the company will obtain FDA approval “within six months,” or by this spring. However, things look on the contrary and we will have to wait and see how Neuralink will respond to it.

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