“There’s all this hype and excitement about BCI, about where it might go,” Oxley continued. “But the reality is, what’s it gonna do for patients? We describe this problem for patients, not around wanting to super-augment their brain or body, but wanting to restore the fundamental agency and autonomy that [able-bodied people] take for granted.”

Around 31,000 Americans currently live with Amyotrophic lateral sclerosis (ALS) with another 5,000 diagnosed every year. Nearly 300,000 Americans suffer from spinal cord paralysis, and another approximately 18,000 people join those ranks annually. Thousands more are paralyzed by stroke and accident, losing their ability to see, hear or feel the world around them. And with the lack of motor control in their extremities, these Americans can also lose access to a critical component of modern life: their smartphone.

“[A smartphone] creates our independence and our autonomy,” Oxley said. “It’s communicating to each other, text messaging, emailing. It’s controlling the lights in your house, doing your banking, doing your shopping, all those things.”

“If you can control your phone again,” he said. “you can restore those elements of your lifestyle.”

So while Elon Musk promises an fantastical cyberpunk future where everybody knows Kung Fu and can upload their consciousness to the cloud on a whim, startups like Synchron, as well as Medtronic, Blackrock Neurotech, BrainGate and Precision Neuroscience and countless academic research teams, are working to put this transformative medical technology into clinical practice, reliably and ethically.

The best way to a man’s mind is through his jugular vein

Brooklyn-based Synchron made history in 2022 when it became the first company to successfully implant a BCI into a human patient as part of its pioneering COMMAND study performed in partnership with Mount Sinai Hospital. To date, the medical community has generally had just two options in capturing the myriad electrical signals that our brains produce: low-fidelity but non-invasive EEG wave caps, or high-fidelity Utah Array neural probes that require open-brain surgery to install.

Synchron’s Stentrode device provides a third: it is surgically guided up through a patient’s jugular vein to rest within a large blood vessel near their motor cortex where its integrated array of sensors yield better-fidelity signal than an EEG cap without the messy implantation or eventual performance drop off of probe arrays.

“We’re not putting penetrative electronics into the brain and so the surgical procedure itself is minimally invasive,” Dr. David Putrino, Director of Rehabilitation Innovation for the Mount Sinai Health System, explained to Engadget. “The second piece of it is, you’re not asking a neurologist to learn anything new … They know how to place stents, and you’re really asking to place a stent in a big vessel — it’s not a hard task.”

“These types of vascular surgeries in the brain are commonly performed,” said Dr. Zoran Nenadić, William J. Link Chair and Professor of Biomedical Engineering at the University of California, Irvine. “I think they’re clever using this route to deliver these implants into the human brain, which otherwise is an invasive surgery.”

Though the Stentrode’s signal quality is not quite on par with a probe array, it doesn’t suffer the signal degradation that arrays do. Quite the opposite, in fact. “When you use penetrative electrodes and you put them in the brain,” Putrino said, “gliosis forms around the electrodes and impedances change, signal quality goes down, you lose certain electrodes. In this case, as the electrode vascularizes into the blood vessel, it actually stabilizes and improves the recording over time.”

A device for those silent moments of terror

“We’re finally, actually, paying attention to a subset of individuals with disabilities who previously have not had technology available that gives them digital autonomy,” Putrino said. He points out that for many severely paralyzed people, folks who can perhaps wiggle a finger or toe, or who can use eye tracking technology, the communication devices at their disposal are situational at best. Alert buttons can shift out of reach, eye tracking systems are largely stationary tools and unusable in cars.

“We communicate with these folks on a regular basis and the fears that are brought up that this technology can help with,” Putrino recalls. “It is exactly in these silent moments, where it’s like, the eye tracking has been put away for the night and then you start to choke, how do you call someone in? Your call button or your communication device is pushed to the side and you see the nurse starting to prepare the wrong medication for you. How do you alert them? These moments happen often in a disabled person’s life and we don’t have an answer for these things.”

With a BCI, he continued, locked-in patients are no longer isolated. They can simply wake their digital device from sleep mode and use it to alert caregivers. ”This thing works outside, it works in different light settings, it works regardless of whether you’re laying flat on your back or sitting up in your chair,” Putrino said. “Versatile, continuous digital control is the goal.”

Reaching that goal is still at least half a decade away. “Our goal over the next five years is to get market approval and then we’ll be ready to scale up that point,” Oxley said. The rate of that scaling will depend on the company’s access to cath labs. These are facilities found in both primary and secondary level hospitals so there are thousands of them around the country, Oxley said. Far more than the handful of primary level hospitals that are equipped to handle open-brain BCI implantation surgeries.

A show of hands for another hole in your head

In 2021, Synchron conducted its SWITCH safety study for the Stentrode device itself, implanting it in four ALS patients and monitoring their health over the course of the next year. The study found the device to be “safe, with no serious adverse events that led to disability or death,” according to a 2022 press release. The Stentrod “stayed in place for all four patients and the blood vessel in which the device was implanted remained open.”

Buoyed by that success, Synchon launched its headline-grabbing COMMAND study last year, which uses the company’s entire brain.io system in six patients to help them communicate digitally. “We’re really trying to show that this thing improves quality of life and improves agency of the individual,” Putrino said. The team had initially expected the recruitment process through which candidate patients are screened, to take five full years to complete.

Dr. Putrino was not prepared for the outpouring of interest, especially given the permanent nature of these tests and quality of life that patients might expect to have once they’re in. “Many of our patients have end-stage ALS, so being part of a trial is a non-trivial decision,” Putrino said. “That’s like, do you want to spend what maybe some of the last years of your life with researchers as opposed to with family members?”

“Is that a choice you want to make for folks who are considering the trial who have a spinal cord injury?” asked Putrino, as those folks are also eligible for implantation. “We have very candid conversations with them around, look, this is a gen one device,” he warns. “Do you want to wait for gen five because you don’t have a short life expectancy, you could live another 30 years. This is a permanent implant.”

Still, the public interest in Synchron’s BCI work has led to such a glut of interested patients, that the team was able to perform its implantation surgery on the sixth and final patient of the study in early August — nearly 18 months ahead of schedule. The team will need to continue the study for at least another year (to meet minimum safety standards like in the previous SWITCH study) but has already gotten permission from the NIH to extend its observation portion to the full original five years. This will give Synchron significantly more data to work with in the future, Putrino explained.

How we can avoid another Argus II SNAFU

Our Geordi LaForge visor future seemed a veritable lock in 2013, when Second Sight Medical Products received an FDA Humanitarian Use Device designation for its Argus II retinal prosthesis, two years after it received commercial clearance in Europe. The medical device, designed to restore at least rudimentary functional vision to people suffering profound vision loss from retinitis pigmentosa, was implanted in the patient’s retina and converted digital video signals it received from an external, glasses-mounted camera into the analog electrical impulses that the brain can comprehend — effectively bypassing the diseased portions of the patient’s ocular system.

With the technical blessing of the FDA in hand (Humanitarian Use cases are not subject to nearly the same scrutiny as full FDA approval), Second Sight filed for IPO in 2013 and was listed in NASDAQ the following year. Seven years after that, the company went belly up in 2020, declared itself out of business and wished the best of luck to the suckers who spent $150k to get its hardware hardwired into their skulls.

“Once you’re in that [Humanitarian Use] category, it’s kind of hard to go back and do all of the studies that are necessary to get the traditional FDA approvals to move forward,” Dr. An Do, Assistant Professor in the Department of Neurology at University of California, Irvine, told Engadget. “I think the other issue is that these are orphan diseases. There’s a very small group of people that they’re catering to.”

As IEEE Spectrum rightfully points out, one loose wire, one degraded connection or faulty lead, and these patients can potentially re-lose what little sight they had regained. There’s also the chance that the implant, without regular upkeep, eventually causes an infection or interferes with other medical procedures, requiring a costly, invasive surgery to remove.

“I am constantly concerned about this,” Putrino admitted. “This is a question that keeps me up at night. I think that, obviously, we need to make sure that companies can in good faith proceed to the next stage of their work as a company before they begin any clinical trials.”

He also calls on the FDA to expand its evaluations of BCI companies to potentially include examining the applicant’s ongoing financial stability. “I think that this is definitely a consideration that we need to think about because we don’t want to implant patients and then have them just lose this technology.”

“We always talk to our patients as we’re recruiting them about the fact that this is a permanent implant,” Putrino continued. “We make a commitment to them that they can always come to us for device related questions, even outside the scope of the clinical trial.”

But Putrino admits that even with the best intentions, companies simply cannot guarantee their customers of continued commercial success. “I don’t really know how we safeguard against the complete failure of a company,” he said. “This is just one of the risks that people are going to take coming in. It’s a complex issue and it’s one I worry about because we’re right here on the bleeding edge and it’s unclear if we have good answers to this once the technology goes beyond clinical trials.”

Luckily, the FDA does. As one agency official explained to Engadget, “the FDA’s decisions are intended to be patient-centric with the health and safety of device users as our highest priority.” Should a company go under, file bankruptcy or otherwise be unable to provide the services it previously sold, in addition to potentially being ordered by the court to continue care for its existing patients, “the FDA may also take steps to protect patients in these circumstances. For example, the FDA may communicate to the public, recommendations for actions that health care providers and patients should take.”

The FDA official also notes that the evaluation process itself involves establishing whether an applicant “demonstrates reasonable assurance of safety and effectiveness of the device when used as intended in its environment of use for its expected life … FDA requirements apply to devices regardless of a firm’s decision to stop selling and distributing the device.”

The Synchron Switch BCI, for its part, is made from biologically inert materials that will eventually be reabsorbed into the body, “so even if Synchron disappeared tomorrow, the Switch BCI is designed to safely remain in the patient’s body indefinitely,” Oxley said. “The BCI runs on a software platform that is designed for stability and independent use, so patients can use the platform without our direct involvement.”

However, this approach “is not sufficient and that, given BCIs’ potential influence on individuals and society, the nature of what is safe and effective and the balance between risk and benefit require special consideration,” argued a 2021 op-ed in the AMA Journal of Ethics. “The line between therapy and enhancement for BCIs is difficult to draw precisely. Therapeutic devices function to correct or compensate for some disease state, thereby restoring one to ‘normality’ or the standard species-typical form.” But what, and more importantly who, gets to define normality? How far below the mean IQ can you get before forcibly raising your score through BCI implantation is deemed worthwhile to society?

The op-ed’s authors concede that “While BCIs raise multiple ethical concerns, such as how to define personhood, respect for autonomy, and adequacy of informed consent, not all ethical issues justifiably form the basis of government regulation.” The FDA’s job is to test devices for safety and efficacy, not equality, after all. As such the authors instead argue that, “a new committee or regulatory body with humanistic aims, including the concerns of both individuals and society, ought to be legislated at the federal level in order to assist in regulating the nature, scope, and use of these devices.”

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What the scientists did was engineer A. baylyi bacteria so that they'd contain long sequences of DNA mirroring the DNA found in human cancer cells. These sequences serve as some sort of one-half of a zipper that locks on to captured cancer DNA. For their tests, the scientists focus on the mutated KRAS gene that's commonly found in colorectal tumors. If an A. baylyi bacterium finds a mutated DNA and integrates it into its genome, a linked antibiotic resistance gene also gets activated. That's what the team used to confirm the presence of cancer cells: After all, only bacteria with active antibiotic resistance could grow on culture plates filled with antibiotics.

While the scientists were successfully able to detect tumor DNA in mice injected with colorectal cancer cells in the lab, the technology is still not ready to be used for actual diagnosis. The team said it's still working on the next steps, including improving the technique's efficiency and evaluating how it performs compared to other diagnostic tests. "The most exciting aspect of cellular healthcare, however, is not in the mere detection of disease. A laboratory can do that," Dan Worthley, one of the study's authors, wrote in The Conversation. In the future, the technology could also be used for targeted biological therapy that can deploy treatment to specific parts of the body based on the presence of certain DNA sequences.

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Brain-Computer Interfaces (BCIs) are devices that monitor the analog signals produced by your gray matter and convert them into the digital signals that computers understand — like a mixing soundboard’s DAC unit but what fits inside your skull. For this study, researchers led by Dr. Edward Chang, chair of neurological surgery at UCSF, first implanted a 253-pin electrode array into speech center of the patient’s brain. Those probes monitored and captured the electrical signals that would have otherwise driven the muscles in her jaw, lips and tongue, and instead, transmitted them through a cabled port in her skull to a bank of processors. That computing stack housed a machine learning AI which, over the course of a few week’s training, came to recognize the patient’s electrical signal patterns for more than 1,000 words.

But that’s only the first half of the trick. Through that AI interface, the patient is now able to write out her responses, much in the same way Synchron’s system works for folks suffering from locked-in syndrome. But she can also speak, in a sense, using a synthesized voice trained on recordings of her natural voice from before she was paralyzed — same as we’re doing with our digitally undead celebrities.

What’s more, the researchers teamed up with Speech Graphics, the same company that developed the photorealistic facial animation technology from Halo Infinite and The Last of Us Part II, to create the patient’s avatar. SG’s tech “reverse engineers” the necessary musculoskeletal movements a face would make based on analysis of the audio input, then feeds that data in real-time to a game engine to be animated into a lagless avatar. And since the mental signals from the patient were mapped directly to the avatar, she could express emotion and communicate nonverbally as well.

“Creating a digital avatar that can speak, emote and articulate in real-time, connected directly to the subject’s brain, shows the potential for AI-driven faces well beyond video games,” Michael Berger, CTO and co-founder of Speech Graphics, said in a press statement Wednesday. “Restoring voice alone is impressive, but facial communication is so intrinsic to being human, and it restores a sense of embodiment and control to the patient who has lost that.“

BCI technology was pioneered in the early 1970s and has been slowly developing in the intervening decades. Exponential advancements with processing and computing systems have recently helped reinvigorate the field, with a handful of well-funded startups currently vying to be first through the FDA’s regulatory device approval process. Brooklyn-based Synchron made headlines last year when it was the first company to successfully implant a BCI in a human patient. Elon Musk’s Neuralink entered restricted FDA trials earlier this year after the company was found to have killed scores of porcine test subjects in earlier testing rounds.

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This new sensor technology is thin enough to sit directly on a kidney's fibrous layer — called the renal capsule — which surrounds and protects the organ. The device works by continuously monitoring changes to blood flow and temperature. The built-in thermometer can sense increases as minuscule as 0.004 degrees Celsius. Once an irregularity is detected, the sensor, which contains a micro coin cell battery for power, uses Bluetooth to alert a patient or physician via a smartphone or tablet. Any increase typically signals inflammation which is a potential sign of transplant rejection.

After any surgery that involves an organ transplant, the risk of rejection is high. The sensor was developed specifically for kidney transplants but it could also work for other organs, including the liver and lungs. Kidney transplants in the US are on the rise and are usually recommended for people who will not be able to live without dialysis. The American Kidney Fund cites that an acute rejection of a kidney transplant one month after surgery happens in about five to twenty percent of patients that go under.

That’s why it is critical to detect transplant rejection, which occurs when your body's immune system treats the new organ like a foreign object and attacks it. If a healthcare provider detects signs of rejection early enough, medical intervention can preserve the new organ in the new host. Northwestern researchers said that the device detected warning signs of organ rejection three weeks earlier than current monitoring methods. The current “gold standard” for detecting rejection is a biopsy, where a tissue sample is extracted from the transplanted organ and then analyzed in a lab. However, biopsies are invasive and can cause bleeding and increase the risk for infection.

Despite developing an innovative first-of-its-kind product, researchers at Northwestern University still have a long way to go. It still needs to be tested on humans in a clinical setting before it can make any impact in the surgical market. Northwestern’s John A. Rogers, a bioelectronics expert who led the device development, said in a statement that his team is now evaluating ways to recharge the coin cell battery so that it can last a lifetime.

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Per the company's announcement, the PRIME study "aims to evaluate the safety of our implant (N1) and surgical robot (R1) and assess the initial functionality of our BCI for enabling people with paralysis to control external devices with their thoughts." As such, this study is looking primarily for "those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS)," despite Musk's repeated and unfounded claims that the technology will be useful as vehicle for transhumanistic applications like learning Kung Fu from an SD card, uploading your consciousness to the web and controlling various household electronics with your mind.

Actually, that last one is a real goal of both the company and the technology. BCIs operate as a bridge between the human mind and machines, converting the analog electrical signals of our brains into digital signals that machines understand. The N1 system from Nueralink leverages a high-fidelity Utah Array of hair-thin probes that, unlike Synchron's Stentrode, must be installed via robotic keyhole surgery (performed by Nerualink's sewing machine-like R1 robot surgeon). This array will be fitted onto the patient's motor cortex where it will record and wirelessly transmit electrical impulses produced by the region to an associated app which will interpret them into actionable commands for the computer. "The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone," the release reads.

Neuralink has been working on the N1 system since 2017, one of the first companies in the industry to begin publicly developing a commercial BCI. However, Neuralink's efforts were waylaid last year after the company was credibly accused of causing the needless suffering and death of dozens of animal test subjects, which led to both a USDA investigation on animal cruelty charges and instigated the FDA to deny the company's request to fasttrack human trials. The PRIME study is being conducted under the auspices of the investigational device exemption (IDE), which the FDA awarded Neuralink this past May.

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More specifically, sweat lactate, which is an organic acid that the body produces during exercise and normal metabolic activity. Because the ear contains sweat glands and is anatomically adjacent to the brain, earbuds are an ideal tool to gather this kind of data.

You may be wondering why scientists are interested in collecting biometric info about brain activity at the intersection of human sweat. Together, EEG and sweat lactate data can be used to diagnose different types of seizures. There are more than 30 different types of recorded seizures, which are categorized differently according to the areas of the brain that are impacted during an event.

But even beyond diagnostics, these variables can be helpful if you want to get a better picture of personal performance during exercise. Additionally, these biometric data points can be used to monitor stress and focus levels.

And while in-ear sensing of biometric data is not a new innovation, the sensor technology is unique in that it can measure both brain activity and lactate. However, what’s more important is that the researchers believe, with more refinement and development, we will eventually see more wearables that use neuroimaging sensors like the one being made to collect health data on everyday devices. In a statement, UC San Diego bioengineering professor Gert Cauwenberghs said that, “Being able to measure the dynamics of both brain cognitive activity and body metabolic state in one in-ear integrated device,” can open up tremendous opportunities for everyday health monitoring.

Throughout the development of the sensor technology, the researchers had to grapple with some obstacles. They needed to make the sensors as small and thin as possible so that they could collect tiny sweat samples. They also had to integrate “components that can bend” to account for the irregular shape of the ear according to Ernesto De La Paz, a Ph.D. alumnus who co-authored the research.

One primary technical challenge was being able to fit the sensors in the ear, specifically in the tragus of the ear, which is an anatomically unique space situated in front of the ear canal that can vary from one individual to another. This led the researchers to create a “stamp-like stretchable sensor,” which can be easily tacked onto an earbud’s surface.

But in order to make sure that the sensors would actually have direct contact with the ear and accurately pick up readings, researchers opted for 3D printed, spring-loaded sensors that “hold contact but can adjust as earbuds move.” The biometric sensors also had to be covered with a hydrogel film that made sure they would amply collect sweat from a wearer.

Despite their capabilities and rosy future as a potential diagnostic aid, the 3D printed sensors really need a considerable amount of sweat in order to be useful for data analysis. But the researchers said down the line the sensors will be more precise, so hard workouts may not be necessary for meaningful sweat analysis.

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In the Oxford study, 74 patients with Parkinson’s were monitored for disease progression over a period of 18 months. The participants wore wearables with sensors in different regions of the body: on the chest, at the base of the spine and on each wrist and foot. These sensors — which had gyroscopic and accelerometric capabilities — kept tabs on 122 different physiological measurements, and tracked the patients during walking and postural sway tests. Kinetic data was then analyzed by custom software programs using machine learning.

The sensor data collected by the wearables were compared to standard MDS-UPDRS assessments, which are considered the gold standard in current practice. That traditional test, in this study’s patients “did not capture any change” while the sensor-based analysis “detected a statistically significant progression of the motor symptoms” according to the researchers.

Having more precise data on the progression of Parkinson’s isn’t a cure, of course. But the incorporation of metrics from wearables could help researchers confirm the efficacy of novel treatment options.

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The charitable organization headed by Priscilla Chan and Meta CEO Mark Zuckerberg has committed $250 million to the effort, according to STAT, alongside investments of $10 million each from the State of New York and New York City. In a blog post announcing CZ Biohub NY, the Chan Zuckerberg Initiative said it will start by focusing on cancers and other diseases that often go undetected until they’ve advanced to the point of being difficult or impossible to treat. That includes “ovarian and pancreatic cancers; neurodegenerative diseases, including Parkinson’s and Alzheimer’s; as well as aging and autoimmunity,” CZI says.

CZ BioHub NY aims to get to the bottom of how immune cells work, down to their ability to spot tissue-specific changes that can be among the earliest indications of a disease’s onset. Then, its researchers hope to be able to create cells that can sniff out these abnormalities even earlier than they’re currently able, and be sent to the disease sites directly for more effective treatment. These bioengineered immune cells would “scout, report, and repair damage to our cells before it leads to serious illnesses,” said Chan.

The New York hub is the latest in CZI’s growing network of research institutions, and joins three others that have been established in San Francisco, Chicago, and Redwood City. All have pledged to break ground on their respective scientific goals within a time frame of 10-15 years. Now, according to STAT, the New York biohub just needs to secure a site to work out of.

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The tool uses magnetic resonance spectroscopy (MRS), which is similar to an MRI. Jamie Near, an Associate Professor at the University of Toronto who specializes in the research of MRS technology told Engadget that, “[an] MRI uses magnetic fields to make images of the distribution of hydrogen protons in water that is abundant in our body tissues. In MRS, the same basic principles are used to detect other chemicals that contain hydrogen.” When a user’s fingertip is placed inside the magnetic field, the frequency of a specific molecule, in this case glucose, is measured in parts per million. While the focus was on glucose for this project, MRS could be used to measure metabolites, according to the Synex, including lactate, ketones and amino acids.

Matthew Rosen, a Harvard physicist whose research spans from fundamental physics to bioimaging in the field of MRI, told Engadget that he thinks the device is “clever” and “a great idea.” Magnetic resonance technology is a common technique used for chemical analysis of compounds, however, traditional resonance technologies operate at high magnetic fields and they’re very expensive.

Synex found a way to get clear readings from low magnetic fields. “They’ve overcome the challenges really by developing a method that has high sensitivity and high specificity,” Rosen says. “Honestly, I have been doing magnetic resonance for thirty years. I never thought people could do glucose with a benchtop machine… you could do it with a big machine no problem.”

Professor Andre Simpson, a researcher and center director at the University of Toronto also told Engadget that he thinks Synex’s device is the “real deal.” “MRI machines can fit an entire human body and have been used to target molecule concentrations in the brain through localized spectroscopy,” he explained. “Synex has shrunk this technology to measure concentrations in a finger. I have reviewed their white paper and seen the instrument work.” Simpson said Synex’s ability to retrofit MRS technology into a small box is an engineering feat.

As of now, there are no commercially available devices that can measure blood glucose non-invasively. While there are continuous glucose monitors on the market that use microneedles, which are minimally invasive, there is still a risk of infection.

But there is competition in the space for no-prick diagnostics tools. Know Labs is trying to get approval for a portable glucose monitor that relies on a custom-made Bio-RFID sensing technology, which uses radio waves to detect blood glucose levels in the palm of your hand. When the Know Labs device was tested up against a Dexcom G6 continuous glucose monitor in a study, readings of blood glucose levels using its palm sensor technology were “within threshold” only 46 percent of the time. While the readings are technically in accordance with FDA accuracy limits for a new blood glucose monitor, Know Labs is still working out kinks through scientific research before it can begin FDA clinical trials.

Another start-up, German company DiaMonTech, is currently developing a pocket-sized diagnostic device that is still being tested and fine-tuned to measure glucose through “photothermal detection.” It uses mid-infrared lasers that essentially scan the tissue fluid at the fingertip to detect glucose molecules. CNBCand Bloomberg reported that even Apple has been “quietly developing” a sensor that can check your blood sugar levels through its wearables, though the company never confirmed. Founder and CEO of Synex, Ben Nashman, told Engadget that eventually, the company would like to develop a wearable. But further miniaturization was needed before they could bring a commercial product to market.

Rosen says he isn’t sure how the sensor technology can be retrofitted for smartwatches or wearables just yet. But he can imagine a world where these tools complement blood-based diagnostics. “Is it good enough for clinical use? I have to leave that for what clinicians have to say.”

Update, November 16 2023, 10:59 AM ET: This story has been updated to clarify that a comment from the company was made by the CEO of Synex and not a company representative.

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PCSK9 was lowered by as much as 84 percent in the cohorts that received higher infusion rates of the treatment. At those higher treatment doses, Verve scientists said that the reduction of those LDL-C-related proteins lasted 2.5 years in previous studies on primates.

From a clinical standpoint, this gene editing therapy has the potential to disrupt the current standard treatment for high cholesterol. The current go-to’s include prescription statins and PCSK9 inhibitors, but they require strict adherence and can have bad side effects like muscle pain and memory loss.

CRISPR, while seemingly miraculous, is a long way from replacing daily medications though. According to Nature, two of the 10 participants in the study suffered from a “cardiovascular event” that coincided with the infusion. Verve says one was not related to the treatment at all and the second was “potentially related to treatment due to proximity to dosing.” The use of a gene-editing technology will always carry some risk because the edits could occur elsewhere in the genome.

Before a single infusion therapy for high cholesterol can reach consumers, the FDA mandates that the treatment will need to be studied for up to 15 years. Verve recently received FDA clearance for an Investigational New Drug Application for VERVE-101, meaning that the company can begin to conduct trials in the US. The current trials in New Zealand and the United Kingdom will look for willing clinical trial participants to expand the study.

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