In June of this year a woman struggling to speak due to motor neuron disease completed a neurosurgical procedure that made her the world’s first person to use the Connexus brain-computer interface, created by Paradromics.

This month, she shared her own thoughts on the implant by using the implant itself, saying, “Okay, I have a lot to say.” The clinical trial participant, a Michigan resident in her 60s, added a message to other people interested in joining a BCI clinical trial: "Don’t be afraid. It’s a wonderful experience to be able to help others by your participation in the research study.”

While speech decoding demonstrations have captured the national spotlight in recent years, Paradromics’ efforts represent a real-time communication breakthrough in a commercial product rather than a research system. That difference is evident in the company’s regulatory strategy, which includes a newly granted FDA approval that will let this participant and all future Connexus users control their own devices at home with a BCI.

Paradromics’ accelerated progress in the last 12 months is remarkable, but has also become typical of the broader shift to commercial readiness in the BCI industry.

Last November Paradromics gained the FDA’s device exemption approval to study their 421-microelectrode array for safety, reliability, and performance in long-term use. This March they launched an application expansion program with research partners driving new work in movement disorders, speech and motor deficits, paralysis and sensor loss, complex control, and speech restoration.

Following officially entry into the clinical stage with their first implant in June, they appointed Dr. William Marks, Jr. as the company’s first chief clinical officer in July. I spoke with Marks to understand what the expanded FDA approval means for patient communities, the company and the field at large.

Convey: Product to Platform

Marks said this approval is about allowing users to embed BCI use into internet-connected devices, to maximize everyday value for them particularly for people with communication difficulties.

“We had requested to untether the user laptop and software from within the confines of the medical device system,” Marks explained. “There’s been a wonderful history of research applications in BCI, but we want to liberate users from being confined by research equipment, and actually make this useful for their everyday needs.”

That means using custom software, known as Convey. “Convey is an interface between all the neural decoding and the outputs that the user is going to use," Marks said. "On their personal laptop, smartphone, or tablet, to empower their own daily use, as opposed to having it be a locked-down medical device.”

He described a device testing and prequalification process to shortlist approved devices that meet certain specs and standards. "The nice thing with this approval is that we don’t have to go back to the FDA every single time and say, “Okay, a patient wants to use an Android phone.”

The approval ensures that downstream output from BCI processing will not impact the implanted device. “It’s different than programming an implantable neurostimulator,” said Marks. “Here, we are not affecting that internal system. We are taking the data off the device and making it more useful for people.”

Beyond enhancing in-home flexibility, expanding the reach of BCI control will impact mobility through wheelchair-mounted devices, open up integration for work-related devices, and open avenues for better caregiver communication.

While “platform” is in vogue to describe multiple clinical indications in BCI, this offers a more human frame: a device-agnostic user-centered technology, more akin to cloud-based email, trans-device operating systems, or a universal remote control.

Bringing live systems online in people’s homes, using their own devices expands the surface area for understanding the clinical, social, and economic impacts of BCI. Marks described several facets of measurement, spanning scientific metrics for data rate, vocabulary size, and decoding accuracy, to the human side of understanding what restorative technology can actually do for people.

“For me as a neurologist,” he said, “The biggest impact is: how does a person’s daily life benefit from this? Restoring or allowing people to maintain capabilities that are so critical to being able to express their needs and interact with family and friends.” He looks ahead at the industry-wide efforts advancing novel outcome measures through efforts underway at the iBCI-CC and beyond.

“I’m sure we’re going to come up with all kinds of creative ways, both as a community and at Paradromics, to understand the impact on daily functions and digital interactivity,” Marks said. “Of course there’s the economic side of removing a burden on people, caregivers, facilities, and payers. Whether it’s looking at real-time communication, or being productive in a part-time or full time job, we’re going to need to make compelling arguments. But as our technology grows more integrated into real-world functions that people need, I think we’ll be able to make that argument more readily and more robustly."

At the clinical level, Marks explains how BCI represents a symbiosis of individualized care and generalized progress. “The concept of personalized care is really apropos here,” he told me. “When we think through the way we do surgery, from the brain imaging to identify optimal targets, visualizing the architecture of the brain surface, tuning the algorithms to the specific wiring, it’s all highly personalized."

And yet these systems cannot take a year to work for a new user, he argues. “That’s why we’re working hard to learn from each participant in this early feasibility study, so we can become more efficient and scale things more quickly,” he adds. Better off the shelf functionality also means less demands on Paradromics’ field team, the participants and their families.

Marks briefly hints at a coming wave of partnered R&D applications powered by the convergence of computing power, algorithms, AI, neural technology, and external hardware, from smartphones to robotics.

In the fast-moving world of BCI, Paradromics faces growing competition from other multi-indication platforms. This year CorTec received its second breakthrough designation from the FDA, for cursor control in quadriplegia following their initial designation for delivering personalized neuromodulation to assist stroke rehabilitation. The company’s Brain Interchange system the same hardware for recording and stimulation. Ability Neurotech reached the human stage of testing their wireless BCI system in Europe this summer, and is preparing for a long-term study.

The question remains how many companies the restorative BCI market can withstand across indications. As non-invasive decoding gets better , led by companies like Synaptrix , investors may cool on writing new checks. But the field already has a pair of unicorn valuations: Neuralink has shared videos of user-driven applications in speech restoration, wheelchair control, and cursor control. They have also been recruiting trial participants for their second implanted product, a visual prosthesis called Blindsight.

Science secured a historic CE mark approval to bring their PRIMA implant to Europe for people suffering from vision loss related to age-related macular degeneration. The company’s leaders have publicly emphasized their goal of upending BCI economics : Revenue from PRIMA sales will help sustain Science’s next-gen clinical R&D, including cutting-edge biohybrid technology that marries personalized proteins with cybernetic control. Even in this niche frontier, several startups building different types of bioengineered neural interfaces are shifting into pre-clinical R&D, including Axo Neurotech, Sam Altman’s Merge Labs, and China’s Gestala.

Science’s regulatory approval marks the second commercial BCI to hit the market this year, following Neuracle’s approval from China’s National Medical Products Administration. Neuracle’s NEO system involves “a coin-sized wireless implant that sits on the surface of the brain’s outer membrane and controls a robotic glove. It is specifically designed for people with spinal cord injuries but is only approved for people who still have some upper arm function.” This description closely matches that of US-based Epia Neuro, who emerged from stealth this spring targeting a first-in-human implanted and wearable system this fall for stroke rehabilitation.

With many more implanted BCI startups angling to enter markets around the world, the question on the global stage is not “how many” but “how fast?”

From Mapping Brains to Charting Geopolitics

On September 2, the National Security Commission on Emerging Biotechnology (NSCEB) released a report calling for US leadership in BCI innovation. The report points to Neuracle’s approval as evidence that Beijing can move from approval to real-world use faster than the US, calling China’s emerging position in BCI a strategic risk to U.S. national security.

The report recommends four policy reforms to drive domestic market readiness, including establishing a national coordination office to address federal bottlenecks, derisking technical readiness through issuing national research challenges, promoting data sharing to train predictive models and decoders, and bridge the “ valley of death ” by simplifying pathways and exempting “familiar products from unnecessary regulation.”

For Paradromics’ founder and CEO Matt Angle, the report’s arrival represents a full-circle moment that happens to coincide with their first implanted end user using a BCI to speak up: Four years ago, Angle’s comments about BCI regulation at a White House meeting convened by the Commerce Department’s Bureau of Industry and Security (BIS) turned into a dedicated two-day BCI Export Controls Conference the following spring.

In that February 2023 meeting, Angle and Paradromics convened a broad range of startups , researchers, advocates, and ethicists to make the case that BCI should not face added regulation that would hurt the field’s ability to advance important clinical and technological development.

As the federal government has shifted its views in a rapidly changing world, the industry has sped out of the research phase into accelerated product development and commercial readiness. One year ago at Mount Sinai’s NYBCI Symposium, Angle shared a dual vision of BCI as a “precisely defined medical device,” as well as a platform technology to turn capital-intensive R&D into “applications that unlock a broader future.”

Washington is listening. And the BCI industry, like Paradromics’ first end user, has a lot to say.