IEEE Biomedical News

IEEE Spectrum
IEEE Spectrum
  • For years, brain-computer interfaces (BCIs) have promised to help people with severe paralysis communicate. The technology is still experimental, but more researchers and companies like Neuralink and Synchron are now testing these devices in human clinical trials. Geneva-based Ability Neurotech is the latest to join their ranks, as it gears up to move its optical BCI from brief tests during surgery toward months-long use in a clinical trial.

    Last month, the company started an intraoperative study in Germany, recording neural signals from patients undergoing brain tumor surgery in brief, 20 to 30-minute sessions. Later stages of the ongoing study will use the device to record brain activity in up to five conscious patients as they perform speech and movement tasks.

    A separate chronic clinical trial in the Netherlands, planned for late 2026, will also test the system over a longer period. As part of a project aiming to develop a BCI to restore speech for paralyzed individuals, University Medical Center Utrecht is recruiting participants for a year-long study in which people with amyotrophic lateral sclerosis (ALS) will receive the implant, train with it at home, and undergo repeated brain-signal recordings.

    Sending Brain Data with Light

    Ability’s system differs from many other experimental BCIs in a few key ways. For one, the implant uses electrocorticography (ECoG) electrode arrays that rest on the brain’s surface—a distinction from other BCI designs that place penetrating electrodes inside brain tissue. It can monitor neural signals from 128 separate channels at once, sampling each 30,000 times every second to capture a highly detailed recording of brain activity.

    Unlike the usual radio frequency transmission method used in wireless electronics, the implant uses an infrared laser-based optical link to stream brain data through the skin at speeds of up to 50 megabits per second. The data is received by an external headpiece and sent to a separate processor for decoding. The wearable also powers the implant wirelessly through induction, eliminating the need for an internal battery that could eventually require replacement.

    Ability Neurotech CEO Rotem Kopel says the company evaluated several ways to handle the large data stream before choosing the optical link. The goal was to get raw recordings out of the implant without reducing them first. Ability doesn’t downsample or compress the data before transmission, leaving decoding and processing to equipment outside the body.

    That extra information can be valuable in decoding, according to Maitreyee Wairagkar, a project scientist in the Neuroprosthetics Lab at the University of California, Davis, who says Ability’s combination of a battery-free design and optical link “sounds very promising for chronic ECoG recordings.”

    “Preserving the information available in raw neural data through transmission is also useful for decoding purposes, since precious data is not lost due to transmission limitations,” Wairagkar says. “I think this is the right focus for longitudinal BCI use, as it offers flexibility over neural feature extraction, which can be useful for improving decoding performance.”

    Ability isn’t alone in pursuing high-bandwidth wireless transmission. Wairagkar says other fully-implantable BCIs, including both ECoG and penetrating-electrode designs, use similar high-bandwidth architectures, with some exceeding 50 Mb/s.

    “Wireless implantable BCIs are still in early days, and we’re seeing multiple new clinical trials being conducted with these devices with varying capabilities in channel counts, signal-to-noise ratio, and data transfer rates, which will determine their performance, functionality, and long-term utility,” Wairagkar says.

    Neurosurgeons implanting a brain-computer interface in an operating room. Ability Neurotech’s BCI was tested during a brain surgery in Germany as part of the company’s first study involving a human patient.ABILITY Neurotech; TU Munich

    Engineering Challenges of BCIs

    Kopel says the implant had to meet several tight engineering constraints, including power and temperature limits. Moving that much data takes power and generates heat, making temperature control a key challenge.

    Engineers also had to route the electrode connections into a hermetically-sealed case designed to keep moisture away from the electronics. The optical link must work through varying skin thickness, blood vessels, and hair, and tolerate imperfect alignment with the external headpiece.

    Kopel says the technology took about 10 years to develop, followed by roughly 18 months of bench, durability, and other validation testing once the design was finalized.

    The upcoming study will test those engineering choices over longer periods. Kopel says the company will first evaluate the implantation procedure and the device’s safety and performance. The next goal is to test whether participants can use the device to control a computer, followed by speech decoding—translating intended speech from brain activity into words in real time.

    Long-Term Support and Durability

    The harder test comes after implantation: keeping the system useful over years of daily life. Software needs updates, brain signals may change over time, and patients could remain dependent on an implant long after the company that built it has changed or disappeared.

    Wairagkar says sustained performance and decoding accuracy over several years are critical for the long-term use of implantable BCIs. “Software challenges, like maintaining and calibrating the decoders and updating the user applications, are easier to solve, but it is important that the underlying signal quality obtained from the device is maintained over long periods,” Wairagkar says.

    Fully-implanted wireless systems already avoid a major durability problem: the permanent connection through the skin used by some BCIs, Wairagkar says. Eliminating that connection can reduce infection risk and help with maintenance and everyday use.

    Long-term support also depends on the company behind the implant. Kopel says Ability has planned for that possibility through its relationship with the nonprofit Wyss Center for Bio and Neuroengineering in Geneva, where the technology was developed before the company spun out in 2025. According to Kopel, if Ability ceased operations, its intellectual property and responsibilities would return to the center.

    Wairagkar says the wider field will need stronger systems for supporting patients as implantable BCIs become more common. Groups are already examining questions around safety, access, and sustainability. Wairagkar added, “As the field matures, there will need to be structures and policies in place to support the use and deployment of implantable BCIs and to provide appropriate services to patients.”

  • When Ryan Hudson-Peralta, a self-described “Apple fanboy,” isn’t using the computer, he’s on his phone. But all of this screentime—and mouse use—can take a toll on his body. Hudson-Peralta, a designer, speaker, and disability advocate, was born with no hands and uses a wheelchair. “With my disability, I was born without shoulder sockets,” he says, and using a traditional computer mouse for an extended period leads to shoulder pain.

    Through a consultancy he founded, Equal Accessibility, Hudson-Peralta sometimes requests test products, whether they’re designed for people with disabilities or not. In 2024, in exchange for feedback on the device, he received a prototype of Mouthpad, an experimental tongue-computer interface, similar to a touchpad on a retainer, which allows hands-free wireless interaction with computers and smartphones.

    In addition to a touch-sensitive area on the roof of the mouth, the Mouthpad incorporates other assistive technologies: a barometer that detects “sip” gestures while also sensing tongue presses; and an accelerometer and gyroscope that track head movement. Designed to be as thin as possible to allow users to speak easily while wearing the device, it is compatible with dictation or voice commands. The device, which communicates via Bluetooth, is removable and rechargeable.

    “The product is incredible,” says Hudson-Peralta. “I thought it was going to be a little bit of a learning curve, but it absolutely was not at all.” He still uses the Mouthpad, generally preferring to control a cursor with head movements and click with the tongue, in rotation with a computer mouse. For the first time in his life, Mouthpad has allowed Hudson-Peralta to do things on a computer away from the desktop, perhaps from the comfort of a couch, and give his shoulder a rest. He believes the device could have even greater benefits for others, for example, some of his friends with paralysis in their upper limbs.

    Now, the Mouthpad may reach a wider audience. In July, it became commercially available to the public. Although the device has been developed prioritizing feedback from people with disabilities that can make it difficult to operate off-the-shelf electronics, such as quadriplegia, it is not being sold as a medical device.

    “If you design for those who are most constrained, you design better interfaces for everybody,” says Tomás Vega, a cofounder of Augmental, developers of the Mouthpad.

    Augmental/YouTube

    A customized experience for all users

    Mouthpad can connect to any device that accepts a Bluetooth mouse. It is expected to be used as an assistive device, directly or indirectly controlling a range of devices including tablets, smartphones, and even sexual aids—all tech used in everyday life that people with physical disabilities may have difficulty controlling.

    Beyond its uses as assistive tech, Mouthpad could also augment workflows or video game experiences as a novel input option, find roles in occupational safety when both device access and free hands are important, and perhaps benefit scientific research. “We believe in universal design,” Vega says.

    Over roughly six years of development, Augmental has added ways to customize Mouthpad inputs to match user preferences and abilities. The physical device also needed to be custom fit because of natural variation in mouth shape and size, and the hardware needed to be thin and flexible, yet durable. “The mouth is the most hostile environment in the body,” says Vega. Despite this, as long as users don’t grind their teeth, Vega expects the number of battery cycles to be the limiting factor for the lifespan of the device, at least two years.

    A single Mouthpad costs US $1,400, which would not be covered by medical insurance, with additional fees for a dental fitting. As one Mouthpad reviewer notes, the device may be eligible for other forms of reimbursement, such as vocational rehabilitation programs.

    Though less expensive computer input options may be available, Hudson-Peralta says that the Mouthpad is “much cheaper” than many of the assistive technologies that he uses and must pay for out of pocket. These devices do not generally have the same economies of scale as mass market electronics.

    Vox tunes in on nearly silent speech

    For many users, the Mouthpad will be one of multiple inputs for devices. Other hands-free computer controllers include mouth-operated joysticks, eye-tracking, and more experimental brain computer interfaces. Voice control is now a common method for inputting text, and along with the release of Mouthpad, Augmental announced a new necklace microphone device, called Vox. If Mouthpad is the mouse, the company says, then Vox is the keyboard.

    Vox is currently able to understand “low-volume speech,” says Vega, but as with most other speech-recognition devices, it can struggle with outside noise or lack user privacy. One long-term goal for the Mouthpad, then, is a fully silent speech interface. That is, the ability to provide the benefits of modern speech interfaces without the need for users to speak audibly, even at a whisper.

    Mouthpad currently only tracks the tip of the tongue; however, articulating certain speech sounds (e.g., k-, r-, and o-sounds) involves the main body of the tongue and the back of mouth, so silent speech may require following movement of the entire tongue. This whole-tongue tracking could open up therapeutic and research applications related to speech.

    For example, some people can articulate their tongue and mouth but are unable to speak conventionally, perhaps due to a removed or damaged voice box. “These patients may experience social isolation and even depression due to their speech or sound disorders,” says Jun Wang, a speech scientist at the University of Texas, Austin, who has worked on a tongue-tracking device.

    Expanding access to tongue-tracking tech

    Augmental is not alone in its efforts to develop mouth-based interfaces.

    Hananeh Esmailbeigi, for instance, is a biomedical engineer at the University of Illinois Chicago who develops wearable technologies, including a “tongue-trackpad.” Without the opportunity to examine the Mouthpad closely, Esmailbeigi declined to comment on specifics of the device, but applauded expanded access to the technology.

    “I am encouraged to see growing attention and investment in this modality and greater public awareness of the potential of intraoral interfaces,” says Esmailbeigi. Beyond computer interaction, she is interested in the devices as a source of quantitative information in rehabilitation for motor control problems that affect speech.

    “I think [tongue interfaces] have great potential due to the high flexibility and endurance of the tongue,” says Lotte N. S. Andreasen Struijk, a biomedical engineer at Aalborg University in Denmark. She helped develop iTongue, which is available in the European Union for computer and powered wheelchair control. Earlier versions of the device required a barbell-shaped tongue piercing to track the tip of the tongue; however, the newest version no longer requires the piercing.

    Assistive devices like Mouthpad can facilitate computer interaction and build technical skills, says Hudson-Peralta. But he emphasizes that access to technology can “help people grow not just in careers, but in social life.”

    This story was updated 13 August to clarify Jun Wang’s area of work.

    This story was updated 21 August to remove “powered wheelchairs” as one of the devices that Augmental’s mouthpad can control.
  • Sixteen viruses is not a large number. But the 16 bacteria-infecting viruses described on 6 August in Science were no ordinary specimens.

    They were not fished out of a sewage outflow or dug up from a soil sample, which is where such things normally come from. They were written by a genomic language model trained on vast troves of DNA sequences. Researchers at Stanford University designed the small viruses from scratch, producing the first complete, functional genomes ever generated by AI.

    And they worked. Delivered together as a cocktail, the designer viruses—known as bacteriophages, or phages—infected E. coli strains that had already evolved resistance to the natural virus they were modeled on, something a comparable mix of natural phages could not do.

    The advance offers a glimpse of a future in which bespoke phage therapies are made to order to combat bacterial infections that antibiotics can no longer touch.

    Phage therapies have been used to treat infectious diseases for more than a century, but the field has struggled with a combination of biological and commercial hurdles: Individual phages often kill only a narrow range of bacteria, resistance can evolve quickly, and naturally occurring phages can be difficult to patent.

    AI-designed phages offer a way around some of those limitations—and Brian Hie, the Stanford computational biologist who led the new study, says collaborators have already begun asking to use their model to create phages capable of killing disease-causing bacteria, rather than targeting a laboratory strain of E. coli.

    But the same AI methods also lower the technical barrier to building other kinds of biological agents on demand, including viruses with the potential to cause disease, sharpening a long-standing worry that systems developed for medicine and biotechnology could be turned, without much modification, into biological weapons.

    “The question is no longer whether generative viral genome design will exist,” a pair of biosecurity experts at the Johns Hopkins Center for Health Security wrote in an accompanying commentary. “It is whether society can build oversight that allows its benefits to unfold while preventing it from enabling serious harm.”

    How the Phages Were Made

    Inside the phrase “designed from scratch” sits a long engineering pipeline.

    The researchers used their Evo 2 foundation model, which was trained on a dataset that included more than 2 million bacteriophage genomes. But for this experiment, the researchers further focused the model on the particular kind of phage they wanted to build—a redesigned version of a much-studied bacteriophage called ΦX174—by fine-tuning it on an additional set of some 15,000 genomes from the target phage’s own relatives.

    They then added computational constraints and quality-control filters to maximize the chances that the AI-generated ΦX174-like sequences would produce working phages. That process yielded 302 candidate genomes.

    Seventeen of these could not be synthesized. Of the remaining 285, the vast majority still failed to infect and kill bacteria—the most basic function of any phage. Only 16 could ultimately be “rebooted,” meaning converted from synthetic DNA sequences into infectious, bacteria-killing phages.

    The result shows that machines can, in fact, write functional viral genomes, albeit relatively small ones containing just 5,400 DNA letters and only 11 genes. But considering the painstaking process it took to produce those 16 working phages, it’s worth asking what exactly the AI contributed, and what would have to change before the method could yield a truly dangerous human pathogen.

    “Right now, I think it would still take a lot of work,” says Hie, who holds a joint appointment at the Arc Institute in Palo Alto, California. “It would definitely require a very talented interdisciplinary team to do this at the moment,” he says—never mind the $100,000–$200,000 in DNA synthesis costs that Hie estimates the project would have cost his team if they had to pay market prices. (Twist Bioscience provided the service at a discount.)

    Hie continues: “Every single virus that you want to reboot in the lab is different and has different experimental conditions that need to be optimized. It needs a lot of domain-specific expertise.” Plus, he adds, “We don’t have a sufficient understanding of how the genetic changes proposed by the AI system lead to improved pathogenicity.”

    How New Are These AI-Designed Phages?

    Before looking too far ahead at what AI-designed viruses might become, it’s also worth asking how much novelty these viruses actually represent.

    An independent analysis of the Stanford data—led by Oliver Crook, a computational biochemist at the University of Oxford—found that the 16 viable phage genomes were on average about 97 percent identical to their ΦX174 template. Placed on a family tree, the AI-designed viruses fell inside the existing spread of phage diversity, rather than branching away from it, Crook concluded.

    In other words, the model was mainly rearranging familiar genetic material into new combinations. “What we saw, at a very plain view, were brothers and sisters of the original virus,” says Crook. “They’re not fundamentally behaving in a new way or using molecular mechanisms that they didn’t before.”

    Sequence novelty, however, does not tell the whole story. Several of the AI-generated phages differed from ΦX174 in their three-dimensional protein structures, growth kinetics, and infection dynamics—properties that ultimately determine how a virus behaves, notes synthetic biologist Samuel King, a graduate student in Hie’s Laboratory of Evolutionary Design and the paper’s first author.

    For example, one of the designed viruses carried an unusually truncated protein that packs DNA into new viral particles. The AI had borrowed this protein from an evolutionarily distant phage and made it work on the ΦX174 genomic backbone by rewiring the surrounding DNA. Notably, an analogous gene swap had previously been shown to be nonviable when introduced into ΦX174 through conventional genetic engineering. “That’s quite a new configuration,” King says.

    For Chase Beisel, a chemical engineer at the Botnar Institute of Immune Engineering, in Switzerland, and cofounder of the phage therapy company Locus Biosciences, such moments show where the real promise of AI-designed phages lies: not in conjuring viruses wholly unlike anything in nature, but in searching through combinations of genetic changes that evolution has never produced and that scientists might never think to test.

    “It’s a novel way to explore sequence space and uncover new attributes,” he says. “That’s going to be really useful in the long run.”

  • On 12 August, just before sunset, a strip of the Iberian Peninsula will witness its first total solar eclipse in more than 120 years. For many across the region, this is a rare chance to see the moon block out the sun. For one group of researchers, it’s an even rarer chance to record the human body’s reaction to that awesome phenomenon.

    For the first time, scientists will monitor those observers with the aid of smartwatches and fitness trackers. In Catalonia, the Solaris project is recruiting wearable device owners to record how their hearts respond to the darkening of the sun. Solaris is an acronym in the Catalan language that translates in English to “Monitoring of Observations of Cardiac and Respiratory Activity during a Solar Eclipse.” The project should log thousands of physiological responses to the eclipse across a vast area.

    Solaris is just the latest example of how medical researchers are turning to wearables for data that can’t be gathered in a lab. “In the past, it has been that you needed somebody to be in the laboratory to be able to collect data on them, and we know that’s just not a great representation of what people’s behaviors and physiology are in everyday life,” says Jessilyn Dunn, a biomedical engineer at Duke University, who isn’t involved with Solaris. “Wearables provide us a window into what’s really going on.”

    Solaris App Tracks Eclipse Heart Data

    Indeed, no Solaris participant will set foot in a lab. The project is open to anyone with a smartwatch, fitness tracker, or another device that can measure its wearer’s heart rate. Those who wish to take part can download the Solaris app, available for both iOS and Android. Several thousand people have already done so.

    As the eclipse nears and as those device-wearers go about their business, the app will record their heart rates and breathing patterns over a five-day period. That span includes the day of the eclipse itself, as well as two days before and two days after to establish a baseline. All data should be anonymized.

    After the eclipse, medical researchers at Barcelona’s Vall d’Hebron Research Institute will have a record of thousands of physiological responses to the same event from across Catalonia. Gathering a dataset like this would have been virtually impossible before the current era of widespread wearables.

    In the future, if researchers want to study how lots of people physiologically respond to one event, they might look to Solaris for inspiration. “I suspect the long-term significance will extend beyond the eclipse itself,”says Michael Chee, a sleep researcher at the National University of Singapore who is also uninvolved with Solaris. “The same approach could be applied to heat waves, pandemics, natural disasters, major sporting events, shift work, or other societal phenomena that affect health and behavior.”

    How Wearables Enable Large-Scale Research

    The same wearable devices that track their users’ sleep schedules, exercise habits, and vital signs can, if users are willing, allow researchers to do the same—on a much larger scale. Other research groups already take advantage of the fact that the owners of wearable devices use them in their everyday lives for years on end.

    “Wearables allow us to collect continuous, objective physiological and behavioral data over months or years in tens of thousands—or even hundreds of thousands—of people,” Chee says. “That is something that was previously impossible with traditional laboratory methods.”

    Sleep researchers like Chee have benefited from the wearable era. Thanks to sleep trackers, they can now sift through millions of real-world nights at once. It’s become far easier to analyze phenomena like the global effects of jet lag or how different countries and age groups sleep differently.

    Wearables have also catalyzed studies of physical activity, thanks to the ready availability of exercise logs from devices like Fitbits.

    From Chee’s perspective, however, wearables are not perfect, and not only because people sometimes forget to charge their smartwatches. Today’s wearables were not designed as precision scientific instruments. In practice, this means that one manufacturer’s smartwatch might measure sleep and physical activity very differently from its competitor’s, which makes researchers’ jobs more complicated.

    Efforts to standardize this are underway, but even if that does happen, wearables will probably never fully replace a proper lab for precise measurements. Instead, these devices’ real value to researchers comes from their ability to gather lots of data in the real world.

    That will be easier as wearables on the market are rapidly growing more capable. “One of the really exciting things is that we can get more types of measurements, a higher frequency of measurements, more accurate measurements,” Dunn says. “That’s improving every day, every year.”

  • When you get a good night’s sleep, you aren’t just giving your brain a chance to rest. Sleep activates a system only discovered in 2012 that washes out brain waste. Called the glymphatic system, it’s comparable to the better-known lymphatic system that moves and filters fluids throughout your body. A healthy glymphatic system is linked to good cognitive function and could prevent neurodegenerative diseases like Alzheimer’s, but monitoring it during sleep has been practically impossible in humans, because today’s methods require noisy, confining MRIs and invasive spinal injections.

    A new wearable device developed by researchers at Georgia Tech and Seoul National University (SNU) could offer a safer and more sleep-friendly alternative. The technology shines near-infrared light to detect brain water, a soup of the fluids that constantly flood your brain. The brain-water mixture contains cerebrospinal fluid (CSF), which is what the glymphatic system uses to flush out waste particles like plaques that block in-brain communication. Measuring total brain water could be a way to study how the glymphatic system moves CSF around to clean the brain, researchers say.

    The patch, the design of which was published this month in Science Advances, is intended for ease of use. It’s the size of a Band-Aid and less than a centimeter thick. Its soft silicone body conforms to the user’s forehead, and it doesn’t require a wired connection during sleep. Plus, it can be recharged and used over multiple nights, capturing more long-term information than what traditional sleep studies and MRIs can.

    “MRI is superexpensive, it’s not really accessible, and more importantly, you cannot sleep under MRI imaging,” says W. Hong Yeo, Peterson Professor in pediatric research at Georgia Tech. “With our device, we can naturally capture conventional sleep right at home.”

    What brain water could say about sleep and the glymphatic system

    The glymphatic system is essentially a network of tiny voids between veins, arteries, and cells that are flooded with CSF when brain cells relax. Sleeves called perivascular spaces, which surround blood vessels, deliver the fluid to the spaces between cells. Dr. Chang-Ho Yun, a professor of neurology at SNU’s Bundang Hospital, says that these intercellular spaces can expand by about 60 percent in sleeping mice, but observations of the change in humans remain indirect.

    “The human brain is densely packed with cells,” Yun says. “During sleep, the alerting signal [noradrenaline] drops away, the cells shrink, and there’s room for cerebrospinal fluid to flow.”

    The new device uses a simple light trick to try to detect CSF changes. If you’ve ever held a flashlight to your palm in a dark room, you’ve seen the beam cause your hand to glow red. That’s because shorter wavelengths of light, like green and blue, are absorbed in your tissue. Red light breaks through and scatters back.

    The patch shines three different wavelengths of near-infrared light: two that are absorbed by blood-cell proteins called hemoglobins, which deliver oxygen to the brain, and one that is absorbed by water. What’s scattered back is picked up by the device’s photodetector. The pattern of absorption at each wavelength reveals how much blood and total brain water lie along the path of the light. Yun says that if total brain water rises while hemoglobin stays flat, the added water is not coming from blood, which could mean CSF is increasing and the glymphatic system is doing its job. This indirect measure is necessary because CSF does not reflect light all that differently from the other fluids in your brain.

    “Although it is indirect evidence, it’s compatible with known theory and known facts demonstrated in animals and humans,” Yun says. In his previous research, he found evidence that suggested glymphatic activity lowers during the REM stage of sleep. The study associated with the new patch, which measured sleep in four people, showed brain-water measurements doing the same during the REM cycle. Still, he emphasizes that further research is necessary to determine if total brain-water changes truly signal glymphatic activity.

    Lauren Hablitz, an assistant professor of translational neuromedicine at the University of Rochester, agrees that it’s hard to say whether the patch is actually monitoring the glymphatic system. Knowing for sure might even be impossible, she adds. “The brain is bathed in fluid, it sits in fluid, it floats in fluid,” she says. “Knowing whether it’s that pool of fluid or the perivascular space or the ventricles that’s changing is hard.”

    But Hablitz, who was not involved in this project, is optimistic about how the new tech can be used, even if it isn’t ultimately measuring the glymphatic system. She says that sleep research is “heavily focused” on electroencephalograms, or EEGs, which use electrodes placed on the scalp to measure the brain’s electrical activity. Yet most people with sleep issues have normal EEG readings, she says.

    “Maybe something like this patch, that can look at another aspect of the biology that isn’t just neuronal activity, can start saying something about what’s actually happening in sleep disruption,” she says.