BCI Competitors Race to Rack Up Human Participants
by James Cavuoto, editor
The market for brain computer interfaces continued to heat up in recent weeks as several vendors announced new milestones in human implantations. As we have noted in previous issues of this publication, the number of new firms entering the space and the amount of venture funding being distributed to startups surpasses any other product category we have seen in the 25 years we have been covering the neurotechnology industry.
While we hesitate to label any firm in this space as a market leader, given the general lack of revenues, Elon Musk’s Neuralink stands out as the leader in attracting funding and media attention, despite their being far behind earlier market entrant BlackRock Neurotech in terms of implanted users. In a recent social media post, the company claimed to now have seven users for its flagship N1 BCI system, four with SCI and three with ALS. “Every single one of our implants in humans is working, and working quite well,” Musk said.
At the recent Neural Interfaces Conference in Arlington, VA earlier this month, Joseph O’Doherty, director of Neuralink’s BCI program and head of the company’s next-gen project, gave an update on the Blindsight visual cortical prosthesis that device incorporates a newly designed 1680-channel stimulation chip called S2. The company hopes to implant its first human participant by next year.
Another vendor, Paradromics, announced the successful completion of its first-in-human procedure with the Connexus BCI. The surgical placement of the device, led by University of Michigan neurosurgeon and biomedical engineer Matthew Willsey, with senior epilepsy surgeon Oren Sagher, and a multidisciplinary team of clinicians and engineers, advances research into the broad potential for intracortical BCIs in brain therapeutics.
Willsey and team demonstrated Connexus can be safely implanted, record electrical brain signals, and be removed intact in less than 20 minutes, using surgical techniques familiar to neurosurgeons worldwide. The Connexus BCI was implanted during an epilepsy resection surgery to better understand how epilepsy influences brain signaling. The procedure confirms the Connexus system can be used in humans, following nearly three years of preclinical studies using the same device.
“This surgery is a key inflection point for Paradromics. We are now a clinical-stage company,” said Matt Angle, CEO and founder of Paradromics. “We’ve known for some time, based on our preclinical studies, that we have developed a world-class BCI platform. Now with the jump to human surgeries and recordings, we are closer to translating this neurotechnology to patients.” This procedure is the first of many surgeries planned over the next several months.
Another firm, ONWARD Medical, announced that two additional individuals with SCI have received ONWARD’s investigational ARC-BCI therapy, bringing the total number of successful implants to five.
These achievements further reinforce ONWARD’s leadership in developing BCI-enabled movement solutions for individuals with SCI. Both procedures were performed at Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, under the direction of Jocelyne Bloch, chief of neurosurgery.
The fourth procedure involved a 48-year-old man with an injury sustained in 2024. The fifth procedure was performed on a 37-year-old woman with an injury from 2011. Detailed results for both participants are expected to be shared in a peer-reviewed scientific publication, consistent with the company’s longstanding reputation for scientific rigor.
“With five successful procedures now completed, we are gaining important information about this potentially transformative therapy for individuals with spinal cord injury,” said Dave Marver, CEO of ONWARD Medical. “Each procedure advances our understanding and refines our approach, bringing us closer to our vision to make thought-driven movement a reality for people living with paralysis.”
Yet another firm Cambridge, MA-based Axoft, announced its first-in-human implant of its BCI in April.
Fresh from announcing its FDA clearance for the Layer 7 Cortical Interface, Precision Neuroscience announced the addition of two senior leadership hires. Vanessa Tolosa, a Neuralink co-founder and expert in microfabricated neural implants, has joined as senior vice president of research and development. Vivek Pinto, former division director at the FDA’s Center for Devices and Radiological Health, has joined as Director of Medical Affairs.
Tolosa is widely recognized for her work developing biocompatible, high-resolution neural interfaces. She began her career at Lawrence Livermore National Laboratory, where she led early work on flexible, polymer-based electrode arrays. As a co-founder of Neuralink, she served as director of neural interfaces and led the company’s microfabrication efforts, including electrode development, packaging, and cleanroom operations. Most recently, she served as a hardware research manager at Meta’s Reality Labs, where she spearheaded the development of next-generation EMG-based wearables.
“I’ve spent my career designing neural interfaces at the edge of what’s possible,” Tolosa said. “Precision brings together technical ambition, clinical insight, and real-world focus. The team isn’t just building a device—they’re rethinking the entire concept of a BCI, including how it’s delivered surgically, which is essential for patient adoption. I’m honored to help bring this technology to people who need it.”
Pinto brings more than two decades of experience across product development, clinical research, and regulatory leadership. During his 12-year tenure at the FDA, he rose from lead scientific reviewer to branch chief and ultimately division director, where he oversaw four teams responsible for the regulation of therapeutic and assistive devices across neuromodulation, physical medicine, and neuropsychiatry. At Precision, he will lead medical affairs, helping bridge clinical evidence generation, effective medical communication, and patient adoption.
“This role taps into everything I care about—collaboration, education, and advancing technologies that make a difference for patients and clinicians,” Pinto said. “What drew me to Precision was the clarity of purpose: a focus on building something that’s innovative, feasible, and grounded in what patients and clinicians actually need. It’s a rare opportunity to help shape where the field is headed.”
Aside from these advances from commercial BCI vendors, a number of research institutions reported progress with human participants.
Researchers at the University of California, Davis, reported progress on an investigational BCI that holds promise for restoring the ability to hold real-time conversations to people who have lost the ability to speak due to neurological conditions.
In a new study published in Nature, the researchers demonstrated how this new technology can instantaneously translate brain activity into voice as a person tries to speak—effectively creating a digital vocal tract with no detectable delay.
The system allowed the study participant, who has ALS, to “speak” through a computer with his family in real time, change his intonation and “sing” simple melodies. “Translating neural activity into text, which is how our previous speech BCI works, is akin to text messaging. It’s a big improvement compared to standard assistive technologies, but it still leads to delayed conversation. By comparison, this new real-time voice synthesis is more like a voice call,” said Sergey Stavisky, senior author of the paper and an assistant professor in the UC Davis department of neurological Surgery. Stavisky co-directs the UC Davis neuroprosthetics lab.
The Davis BCI was able to translate the study participant’s neural signals into audible speech played through a speaker very quickly—one-fortieth of a second. This short delay is similar to the delay a person experiences when they speak and hear the sound of their own voice.
The technology also allowed the participant to say new words (words not already known to the system) and to make interjections. He was able to modulate the intonation of his generated computer voice to ask a question or emphasize specific words in a sentence.
The participant also took steps toward varying pitch by singing simple, short melodies. His BCI-synthesized voice was often intelligible: Listeners could understand almost 60% of the synthesized words correctly (as opposed to 4% when he was not using the BCI).
Carnegie Mellon University professor Bin He has spent over two decades investigating noninvasive BCI solutions, particularly those based on electroencephalography, that are surgery-free and adaptable across a range of environments. His group has achieved a series of groundbreaking milestones using EEG-based BCIs, including the first successful flight of a drone, the first control of a robotic arm, and the first to control a robotic hand for continuous movement.
As detailed in a new study in Nature Communications, He’s lab brought noninvasive EEG-based BCI one step closer to everyday use by demonstrating real-time brain decoding of individual finger movement intentions and control of a dexterous robotic hand at the finger level.
“Improving hand function is a top priority for both impaired and able-bodied individuals, as even small gains can meaningfully enhance ability and quality of life,” explained He, professor of biomedical engineering at CMU. “However, real-time decoding of dexterous individual finger movements using noninvasive brain signals has remained an elusive goal, largely due to the limited spatial resolution of EEG.”
In a first-of-its-kind achievement for EEG-based BCI, He’s group employed a real-time, noninvasive robotic control system that used movement execution and motor imagery of individual finger movements to drive corresponding robotic finger motions. Just by thinking about it, human subjects were able to successfully perform two- and three-finger control tasks. This was accomplished with the assistance of a novel deep-learning decoding strategy and a network fine-tuning mechanism for continuous decoding from noninvasive EEG signals.