Neurotech Advocacy

The FDA signaled a major shift in its approach to regulating brain-computer interface (BCI) companies by no longer requiring approvals on a device-by-device basis for devices that are linked to patients’ BCIs.

Paradromics is a BCI company based in Austin, Texas, with ongoing clinical studies aimed at giving speech for those who cannot produce speech on their own due to motor impairments. The BCI achieves this by recording electrical signals from the patient’s brain, then using an AI-trained decoding algorithm, to convert the patient’s brain signals into a digital output, essentially translating a person’s intent into robotic speech. Its BCI has not yet received FDA approval for commercial use but has recently received letter approval from the FDA to allow its software platform called Convey^TM to run on any device instead of having each device manually approved by the FDA.

The United States and other Western countries do not yet have any BCI currently approved for commercial use, while earlier this year, China approved Neuracle’s BCI for spinal cord injuries, a world first¹.

This “blanket” approval approval by the FDA will make it possible so that Paradromics’ BCI users can obtain the Convey software, on their personal devices. Paradromics’ CEO stated that this would afford its users mobility and convenience².  

Several implications arise out of the FDA’s approval. On the positive, it is a shift towards patient mobility by allowing patients more control over their personal information and device. It is inevitable that for scaling, mass production, and integration to daily life purposes, regulations on BCIs will need to be relaxed to meet the health demands of a large portion of the population who are suffering from ailments which these devices can provide therapeutic relief for. Some compromises on oversight are necessary, but with the expansion of Paradromics’ Convey platform to personal devices, also comes the risk of security breaches and theft of personal information. In this case, the loss of personal information would lead to the loss of the AI decoding algorithm that can translate someone’s thoughts into a tangible output. Those who gain unauthorized access to this data, can also use that information to decode the thoughts of those patients.

Another troubling prospect that continues to permeate the development of BCIs in general, is the priorities to investors that companies like Paradromics have⁴. There exists an underlying tension between patient privacy and safety with the pressure for rapid commercial profits. Paradromics has received extensive funding from several organizations that are either linked to wealthy individuals or sovereign wealth funds like its partnership with Saudi Arabia’s NEOM⁶. It has also received investments from Khosla Ventures – a venture capital fund with links to Peter Thiel⁷.  

As Todd Shryock commented on his news story, this approval is part of broader administrative push to grant early entry ways for remote medical treatments still being validated in real-world settings. However, he compares this approval to examples that are not analogous³.

The sensitivity of the data collected by BCIs, is inherently, vastly riskier and more intimate than the approval of remote medical aid technologies.