Amazon has launched a new subscription service that will let customers in the US get as many eligible medications as they need for $5 a month. The new service called RxPass is part of the e-commerce giant's Pharmacy business that originally launched in 2020 as a two-day prescription drug delivery offering for Prime users. That makes RxPass a $5 add-on for Prime, which sets users back $139 a year or $15 a month in the US.
While it doesn't look quite as affordable bundled with Prime pricing, the RxPass program does offer medications for 80 common health conditions, including high blood pressure, acid reflux, anemia and even depression, diabetes, breast cancer and dementia. At the moment, it has 60 generic medications in its list — all of which require a valid prescription — and subscribers can choose to have them delivered for free either on a monthly or a quarterly basis.
Take note that customers will need to pay $5 out of pocket, since the service does not take insurance like Amazon Pharmacy does for purchases outside of the program. People who are enrolled to Medicare, Medicaid and any other government healthcare program will not be able to sign up for RxPass, as well, though they can still use their government insurance when purchasing medicine from Pharmacy.
For people with multiple conditions paying a lot more than $5 a month for their medications out of pocket, RxPass could be worth trying out, especially if they already have Prime. Those interested may want to take a look at the service's full medication list first to see if it does offer what they need before heading to the Pharmacy website or the Amazon app to sign up.
Stroke patients in the US could soon take advantage of cutting-edge robotics during the recovery process. The Food and Drug Administration has cleared Wandercraft's Atalante exoskeleton for use in stroke rehabilitation. The machine can help with intensive gait training, particularly for people with limited upper body mobility that might prevent using other methods.
The current-generation Atalante is a self-balancing, battery-powered device with an adjustable gait that can help with early steps through to more natural walking later in therapy. While the hardware still needs to be used in a clinical setting with help from a therapist, its hands-free use lets patients reestablish their gait whether or not they can use their arms.
Wandercraft plans to deliver its first exoskeletons to the US during the first quarter of the year, though it didn't name initial customers. It only recently launched its commercial business in the country, but financial backer Quadrant Management says Wandercraft could "significantly scale" its operations within the next one to two years.
FDA-cleared exoskeletons are still relatively rare, and are still limited to helping with specific conditions. Last June, Ekso Bionics received permission to market its EksoNR device for multiple sclerosis rehab. Wandercraft's approval makes the technology accessible for a wider range of patients, and may be especially helpful when strokes are a major cause of long-term disability in the US. Over 795,000 people have a stroke in the country each year — this could help some of them regain freedom of movement.
The humble honeybee hasn’t had an easy go of things recently. Between climate change, habitat destruction, pesticide use and attrition from diseases, one of the planet’s most important pollinators has seen its numbers decline dramatically in recent years. All of that bodes poorly for us humans. In the US, honeybees are essential to about one-third of the fruit and produce Americans eat. But the good news is that a solution to one of the problems affecting honeybees is making its way to farmers.
This week, for the first time, the US Department of Agriculture granted conditional approval for an insect vaccine. A biotech firm named Dalan Animal Health recently developed a prophylactic vaccine to protect honeybees from American foulbrood disease. The drug contains dead Paenibacillus larvae, the bacteria that causes the illness.
Thankfully, the vaccine won’t require beekeepers to jab entire colonies of individual insects with the world’s smallest syringe. Instead, administering the drug involves mixing it in with the queen feed worker bees eat. The vaccine then makes its way into the “royal jelly” the drones feed their queen. Her offspring will then be born with some immunity against the harmful bacteria.
The treatment represents a breakthrough for a few reasons. As The New York Times explains, scientists previously thought it was impossible for insects to obtain immunity to diseases because they don’t produce antibodies like humans and animals. However, after identifying the protein that prompts an immune response in bees, researchers realized they could protect an entire hive through a single queen. The vaccine is also a far more humane treatment for American foulbrood. The disease can easily wipe out colonies of 60,000 bees at once, and it often leaves beekeepers with one choice: burn the infected hives to save what they can.
Dr. Annette Kleiser, the CEO of Dalan, told The Times the company hopes to use the vaccine as a blueprint for other treatments to protect honeybees. “Bees are livestock and should have the same modern tools to care for them and protect them that we have for our chickens, cats, dogs and so on,” she said. “We’re really hoping we’re going to change the industry now.”
One swallow doesn’t make a summer, and I’m not sure if you can count four instances of a product as a trend, but it’s certainly an interesting thread at this year’s CES. At this year’s show, a quartet of companies are showing off urine analysis tools designed to be used at home by the general public. These are positioned as a natural evolution of the fitness tracker, a device you can use to keep an even closer eye on your health and fitness. Most of them are built for your toilet, testing your pee for any number of easy-to-identify maladies. But is this the next great frontier of consumer health tracking? That rather depends on the public’s desire to delve deep into their own bladders.
My cynical take: I suspect the reason we’re seeing these pop up is because the wearables world is now played out. Back in 2019, I wrote that we’d reached the point where there were no new features that could be fitted to a smartwatch, fitness tracker or ring. Or, at least, none that were as valid, effective or accurate as what you now expect every device on the market to offer. Once it was possible to put a single lead ECG in a watch, there were no new health-tracking worlds left to conquer that didn’t involve breaking the skin.
Dr. Audrey Bowden is Dorothy J. Wingfield Philips Chancellor Faculty Fellow, Associate Professor of Biomedical Engineering at Vanderbilt University, and head of the Bowden Biomedical Optics Laboratory. Dr. Bowden tells Engadget that clinical urinalysis is used as a “first line screening for many diseases and conditions such as diabetes and kidney disease,” but added that it can “also play a role in ordinary, routine checkups, such as during pregnancy.”
You may have seen your physician ask you for a urine sample and then stir a dipstick dotted with colored squares of reaction paper into the liquid you’ve just produced. In addition to visually checking urine for cloudiness (an obvious sign of a problem), these squares can run a wide variety of tests as part of this first-line screening process.
Each square corresponds to a different test, looking for factors like pH as well as the presence of blood, or white blood cells. Blood, for instance, can indicate kidney stones or cancer, while white blood cells are a clue your body is fighting an infection. If there’s excess glucose in the urine, it’s likely that diabetes is the culprit. Ketones would indicate ketosis, nitrites could indicate bacteria in the urinary tract, and so on.
Dr. Bowden added that for many conditions, urinalysis is not a “definitive diagnostic, but rather serves as an initial prompt to perform a more complete investigation.” And that since the clinical procedure has been to test for urine when there’s already evidence of a problem, it’s not clear how effective daily testing can really be.
A medical professional I interviewed, who requested anonymity for fear of compromising their professional standing, expressed skepticism both about the accuracy of these tests as well as their utility. They said that if people were running tests at home on a regular basis, it runs the risk of providing hypochondriacs with another reason to clog up care centers.
Dr. Shubha K. De (MD) is a Urologic surgeon who is presently working on a PhD in biomedical engineering. He raised a concern that, in primary care facilities, medical staff know how to validate the data they’re presented with, and to screen out false positives. This may not be the case in an at-home setting, and added that the accuracy of some tests vary wildly — a dipstick test to identify a bladder infection is roughly 80-percent accurate, but to diagnose bladder cancer, it falls to just 3 percent.
The most talked-about gadget at CES is surely Withings’ U-Scan, which even Jimmy Kimmel joked about in his opening monologue on Thursday. Given that Withings is already such a big name in the health-tracking world, it’s little surprise that it’s hogged the attention. The company showed off a device that sits on the dry part of your toilet bowl, and samples some of your trickle as you pee. Once that fluid is captured inside the device, it runs a sample through a microfluidic cartridge (with reaction paper) and uses a reader to look at the result. Once completed, the results are sent to your phone, with suggestions on what you might do to improve your health.
When it’s eventually released, U-Scan will offer a cartridge for menstrual cycle tracking, as well as one to monitor your hydration and nutrition levels. It’s this latter cartridge I tried during my time in Vegas this week, and it looked at the pH of my urine as well as the specific gravity (relative density) of my pee. But the company promises that it will eventually be able to identify nutrient levels, fat metabolism, ketones and quantities of vitamin C.
Both of these have raised red flags with professionals who are concerned that these analyses don’t suit a one-size-fits-all model. Dr. Bowden said that menstrual cycle tracking based on “‘normalization’ curves may have been developed with too narrow a demographic to capture all interested users.”
Dr. Bowden was also resistant to the idea that nutritional information can be extracted given clinical urinalysis doesn’t offer data about those markers. She said urine samples don’t really “provide reliable information over a given time window,” and added that a “daily analysis of food nutritional content may be a stretch.” Although she did say that it may be possible to detect “accumulated nutritional deficits.”
Dr. De, however, says that it may be possible to extrapolate nutritional information back to a person’s diet using urine analysis. They said that physicians currently ask patients to run 24-hour urine collections, and that fluid is then examined for specific substances — like uric acid — to make inferences on dietary intake. “This is not always perfect, and currently needs some correlation with one’s diet history,” but added that it’s plausible to imagine that, with a “user friendly app and some AI” that it could work well.
Withings is looking to develop more clinical tests, and has said that it’s already working on a way to screen for bladder cancer markers. It’s here that my source who asked not to be named feels would offer real value to groups who are at risk of the disease. They said that a targeted monitoring program may help identify instances of the cancer early, which should dramatically increase survival rates.
Daniel Cooper
Korean company Yellosis graduated from Samsung’s startup incubator some years ago, and already produces the Cym Boat personal urine testing kit. Cym Boat offers a small stick with reaction paper squares, which you then stand in a boat-shaped piece of card lined with color-calibration squares. Take a picture on your smartphone, and you’ll be able to look at the blood, protein, ketones, pH and glucose levels within your urine.
At the show, it also showed off its next-generation product, Cym Seat, which uses a metal arm to hold a paper stick under a person as they pee. Once completed, it slides the strip in front of an optical scanner, and after a minute, the results are pushed to your phone. But this device, which is expected to launch by the end of 2023 and cost around $1,000, automates the existing process rather than adding anything new.
Daniel Cooper
Similarly, Vivoo, which also offers a reaction-paper stick which can be analyzed by a smartphone app, is building its own toilet-mounted hardware, which pushes a pee stick into the toilet bowl and then pulls it back in once it’s collected a urine sample. An optical scanner then reads the reaction squares before depositing the stick in a collection bin for disposal later.
Daniel Cooper
Rounding out the group is Olive, which is taking a dramatically different tack. The device harnesses spectroscopy rather than reaction paper, with hardware that sits under your toilet seat, and a bank of LEDs flashing toward rear-mounted photodiodes. The potential for such a technology is far greater than reaction paper, and there are some studies that have pointed to being able to identify infection with it.
Olive is presently being used in a handful of locations in the Netherlands, including an assisted living facility. Co-founder Corey Katz told Engadget that one of the most surprising uses for the technology was for personnel to keep accurate records of patient bathroom visits. Katz added that work is presently under way to find a way to measure levels of protein in urine to identify instances of preeclampsia.
The company says that there’s a broad number of conditions that spectroscopy could be used to test for. This includes hydration and ketosis all the way through to stress, creatinine levels and electrolyte balances. The hope is that a finished version of the hardware will be ready to go by the end of 2023, although it’ll only be sold to business customers.
There are issues, including around data security, especially for menstrual cycle tracking in countries like the US. Companies that could expose fertility data will need to be mindful of the legal context that is presently in place post-Roe.
If Dr. De has a final concern, it’s a worry that these at-home devices will encourage patients to take medical matters into their own hands without the supervision of a physician. “If [urine analysis systems] direct you to take supplements which jeopardize pre-existing medical conditions,” for instance, “then it could be quite dangerous.”
Of course, there are other things that independent experts (and journalists) will need to test when these devices make it out into the real world. Dr. Bowden raised concerns that urinalysis tests can be “impacted by a number of external factors,” which clinical settings make an effort to control for. Will these devices be accurate enough for the jobs they’ve been bought to do? And will the conclusions they provide be worthwhile? There’s a lot to work through before these products become ubiquitous in bathrooms around the world.
Valencell, best known around these parts for making optical heart rate sensors for fitness tech, has turned up to CES with something new. The company is showing off a new fingertip monitor that, it says, will offer “cuffless” blood pressure monitoring. Rather than inflating a sleeve around the top of your arm, you’ll be able to monitor your blood pressure with a fingertip clip. That’s currently commonly used to measure your heart rate both at home, and in medical settings.
The as-yet unnamed device is pending FDA clearance, but Valencell has explained that it uses PPG sensors to measure blood flow patterns. This information is then run through an algorithm which calculates the movement against both a dataset containing 7,000 patient records. That’s then run up against the user’s age, weight, gender and height to produce a blood pressure measurement. And you’ll get both Diastolic and Systolic results presented on the device’s built-in screen, and pushed to the companion mobile app.
Much as Valencell say its work is unique, we’ve seen at least one other system that uses PPG and algorithms in place of a cuff. At the start of 2022, the University of Missouri showed off its own finger clip that harnesses a pair of PPG sensors, one on either side of the finger. That system was, by its creators own admission, far less accurate for diastolic measures, given the need to control for a person’s age, gender and weight.
Valencell seems to suggest that it has solved those issues with more data, to the point where you won’t need to calibrate its monitor with an initial cuff reading. That’s either some staggering bravado, or a sign that we’re getting better at the nitty-gritty of healthcare monitoring. The company says that it could offer a new weapon in the war against hypertension, and it hopes to offer it for use in clinical settings for remote patient monitoring or chronic care management.
But that’ll all have to wait until the FDA has run its cautious eye over the hardware — which could take much of the year — but if it offers its blessing, Valencell says it’ll sell the product for $99.
Every year, many of us put things like “eat better,” “stress less” and “get in shape'' on our New Year’s resolutions lists. And sleep can play a big part in achieving all of those goals. Missing out on rest makes us eat junk and pumps up stress hormones to the detriment of pretty much every other way we try to better ourselves. Thankfully, technology can help; in addition to just reminding us to take enough time to sleep, as the bedtime modes on your iPhone or Android device do, there are other gadgets that can help make the sleep you do get deeper and more restful. For those who need a little extra help getting some shut-eye in 2023, here are a few gadgets to help you sleep that we've tried that could work for you, too.
Oura Ring
Oura’s smart ring tracks your activity during the day and your sleep at night (or whenever it is you go to bed), giving you an overall score from one to 100 each morning. Using temperature, movement, blood oxygen and pulse sensors, Oura gains insight into how long you stay in the various sleep stages and uses that data to offer suggestions on ways to get better quality rest. When we tested it out, we called it the “perfect wearable for people who don’t like wearables,” appreciating the data it provides while slipping seamlessly into everyday life. After a few days of wearing it, our reviewer quickly started to ignore its presence, which means you’re probably much more likely to wear it to bed than a fitness band.
Since it doesn’t have a screen, all of Oura’s information comes to you via the companion app. That lack of screen is also the reason you can squeeze up to seven days of battery life out of it, an important feature since no device can track your sleep if it has to spend its nights on a charger.
Fitbit Inspire 3
If you prefer a wearable with a screen, a fitness tracker is arguably better than a smartwatch when it comes to sleep tracking since they tend to be less obtrusive and have longer battery life. That means you’re more likely to wear it to bed many nights in a row, until it eventually has to be recharged. Far more affordable than the Oura, Fitbit’s Inspire 3 is our budget pick for the best fitness tracker right now, and it does a good job tracking your Zs.
It runs for around $100 and has similar sensors to the Oura, including heart rate, temp, movement and blood oxygen. The company has put a lot of effort into expanding their sleep metrics, and the app can offer you detailed insights into how long you’re spending in each stage of sleep. Even without the premium membership, you’ll get a sleep score each morning. With the $10-per-month membership, you get a more detailed breakdown of the score, so you can better track your sleeping trends over time. Along with that, the alarm on the Inspire 3 can wake you up when you’re in a lighter sleep stage so coming back online isn’t as jarring.
Eight Sleep Pod 3
If you don’t want a wearable at all, the Sleep Pod 3 from Eight Sleep will track your metrics and give you a sleep score. It also heats or cools your side of the bed and wakes you up with a subtle rumble beneath your chest. The mattress-and-cover combo goes for between $3,000 and $4,400, depending on the size and thickness of the mattress, which puts it well above any traditional wearable in terms of affordability. The bulk of the cost is in the cover, which conceals tubing through which warm or cool water flows from an external base, regulating the temp, while sensors in the cover monitor your sleep.
You can buy the cover alone and that will save you between $900 and $1,900 off the sticker price, but it’s still not cheap. You’ll also need a $19 per month subscription to access all the sleep tracking features. But in our review, with a score of 81, our reviewer (and new dad) Sam Rutherford said the Pod 3 has delivered some of the best sleep he’s ever had.
Hatch Restore
Part sunrise alarm clock, part audio machine, the Hatch Restore made the cut in our guide to smart lights for its ability to help out before, during and after sleep. To get you to dreamland, the Restore offers guided exercises and sleep stories, and to keep you asleep once you get there, you have your pick of white or pink noise sounds. To wake up, the gentle sunrise alarm slowly brightens, mimicking the sunrise and priming your brain for morning. The caveat here is that you’ll need a subscription to access the library of sleep meditations and guides, and that currently goes for $5 a month or $50 per year.
Headspace
Personally, the best thing I’ve done for my sleep is banishing my phone from the bedroom, so it may seem ironic to add a smartphone app to this list. Headspace, however, has the opposite effect on sleep that social media does. Like the Hatch Restore, this app has an extensive library of meditations and exercises to help you relax and fall asleep.
I prefer the shorter, wind-down segments that last a few minutes and help you do a full body scan to relax. Longer “Sleepcasts” run around 45 minutes and tell you stories in calm voices – there are even a few Star Wars-themed tales, but those just made me want to get up and watch more Andor. Sleep music and soundscapes combine ambient sounds with tones and melodies, lasting up to 500 minutes. And perhaps most critically, there’s a “Nighttime SOS” page, with guided exercises to help you get back to sleep if you wake up with bad dreams, work stress or something else.
A subscription goes for $70 a year or $13 a month. In addition to sleep content, you also get daytime meditations and sessions that help you breathe, focus and manage stress, which can also help with sleep. If you do decide to bring Headspace into the bedroom, make sure you have your phone’s sleep focus or bedtime mode turned on before you do, otherwise nighttime spam emails and Messenger alerts will undo all of the good work your sleep app just rendered.
Philips Hue Smart Lights
We think Philips Hue White + Color are the best smart light bulbs you can buy, and certain features can even help with sleep, such as programming them to change to a warmer color when it's getting close to bedtime. You not only get a subtle hint that it’s time to wind down, but also the warmer tones have lower levels of sunlight-mimicking blue light and can help your brain prepare for sleep. You also have the ability to control them using your voice, so instead of getting out of bed to shut off the lights, you can ask Alexa or the Google Assistant to do it for you.
Felix Gray blue light blocking glasses
Speaking of blue light, it’s not great for sleep. But the habit of staring at screens isn’t going anywhere, which is why blue light-blocking glasses exist. I’ll admit I first thought they were a gimmick, but have since come to rely on the pair I bought from Felix Gray. The science seems to check out and do I notice a difference with my sleep patterns when I wear them versus when I don’t. I initially only wore them in the evening hours, when I was working past 5PM or otherwise still using my computer. Now I wear them basically all day because I feel like they help my eyes feel far less tired. They come with or without your prescription and in enough styles to make them your own.
Bearaby weighted blanket
You’ve probably met someone who swears by their weighted blanket. Our colleague Nicole Lee is one of them. As someone plagued by insomnia, she finds she’s “nodding off faster and staying asleep longer” with the Bearaby weighted blanket and recommends it as one of our top self-care gifts. Unlike other weighted blankets that are filled with glass or plastic beads, Bearaby comforters are hand-knit from a heavyweight cotton, Tencel or eco-velvet, looking more like enormous scarves than a bland sleep aid.
Manta sleep mask
While blue light is bad before bed, any type of light hitting your eyelids can keep you from reaching those deeper levels of sleep. Along with blackout curtains and shutting off the nightlight, we recommend this sleep mask from Manta. There are a ton of sleep masks out there, but Engadget weekend editor Igor Bonifacic finds this one to be better than the rest and recommends it for travelers in our guide. It has removable, repositionable eye cups for a customized fit and they stand up to their claim of blocking out 100 percent of ambient light. You can also buy additional eye cups that you can microwave to provide a warming effect, or eye cups wrapped in silk that will be gentler on your skin and others.
As we approach the end of the year, it’s time for Engadget to wrap up the successes and failures in tech from the last twelve months. While it might be easier point out the messes made by the likes of crypto, Google’s Stadia cloud gaming platform and, ugh, Twitter, there were some highlights too. These include the eventual arrival of Steam’s handheld gaming PC, all those Wordle options, and some dazzling new views of space. The worst of 2022 centers an awful lot on tech bros, if you hadn’t rolled your eyes at them enough in the preceding years. From the collapse of FTX to the precarious state of Twitter, it’s been a mess. Meanwhile, the likes of Peloton have struggled to hold onto their pandemic user base, and Toyota’s EV efforts haven’t been great. Check out all our hits and our misses of 2022.
– Mat Smith
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No word yet on when the company expects to launch the service.
A report from The Information says that Amazon is working on a new standalone streaming app to declutter Prime Video and better highlight its deals with the NFL, the UK’s Premier League and New York Yankees. The development follows recent comments from Amazon CEO Andy Jassy, who highlighted live sports content as one of the areas where the company plans to continue spending money even as it cuts costs in other areas. The Information says it doesn’t know when Amazon might release the app, nor if the company plans to charge separately for access to Prime Video’s sports content. The outlet also notes Amazon may decide to shelve the app. Amazon did not immediately respond to Engadget’s comment request. Earlier this month, Google reportedly agreed to pay between $2.1 billion and $2.2 billion for the NFL’s Sunday Ticket package.
Health company Movano has teased its first smart ring, the Evie, designed for health, fitness and cycle tracking. It looks like a rival to Oura's latest smart ring, though the company says it's "designed uniquely for women." It offers many of the health metrics seen on Oura's ring and wearables from Apple and others. It can measure heart rate, blood-oxygen, skin temperature variability, steps, calories, sleep, period and ovulation tracking, and more. Movano plans to provide a closer look next week at CES 2023.
Marvel announced the news on Lee’s 100th birthday.
Yesterday was Marvel legend Stan Lee's 100th birthday and the comic giant marked the occasion by revealing that a documentary about his life will hit Disney+ next year. Lee, who died in 2018, is a critical part of Marvel’s legacy. The many, many characters he’s credited with co-creating include Spider-Man, Iron Man, Black Panther, Ant-Man, X-Men, The Fantastic Four and The Incredible Hulk. Disney has mined its history for several documentary projects for its streaming service. When Disney+ debuted three years ago, it featured a docuseries on the Imagineers, the minds behind its theme parks.
The test could replace lumbar punctures and brain scans.
When doctors need to confirm an Alzheimer's diagnosis, alongside brain scans, it can involve a lumbar puncture – an invasive and painful procedure that’s more commonly known as a spinal tap. The next best tool for diagnosing Alzheimer’s disease is a blood test. While some tests can detect abnormal tau protein counts as a possible indicator of Alzheimer’s disease, they’re less effective at spotting the telltale signs of neurodegeneration. But this week, in the journal Brain, a multinational team of researchers from Sweden, Italy, the UK and US detailed a new antibody-based blood test that can detect brain-derived tau proteins specific to Alzheimer’s disease. Following a study of 600 patients, the team found their test could reliably distinguish the illness from other neurodegenerative diseases.
When doctors need to confirm an Alzheimer's diagnosis, they often turn to a combination of brain imaging and cell analysis. Both have their downsides. The latter involves a lumbar puncture, an invasive and painful procedure that’s more commonly known as a spinal tap. A doctor will insert a needle into the lower back to extract a sample of the patient’s cerebrospinal fluid. A lab technician then tests the sample for signs of progressive nerve cell loss and excessive amyloid and tau protein accumulation. MRI scans are less invasive but they’re often expensive and accessibility is an issue; not every community has access to the technology.
The next best tool for diagnosing Alzheimer’s disease is a blood test. While some can detect abnormal tau protein counts, they’re less effective at spotting the telltale signs of neurodegeneration. But that could soon change. This week, in the journal Brain, a multinational team made up of researchers from Sweden, Italy, the UK and US detailed a new antibody-based blood test they recently developed. The new test can detect brain-derived tau proteins, which are specific to Alzheimer’s disease. Following a study of 600 patients, the team found their test could reliably distinguish the illness from other neurodegenerative diseases.
Dr. Thomas Karikari, a professor of psychiatry at the University of Pittsburgh and one of the co-authors of the study, told The Guardian he hopes the breakthrough could help other researchers design better clinical trials for Alzheimer’s treatments. “A blood test is cheaper, safer and easier to administer, and it can improve clinical confidence in diagnosing Alzheimer’s and selecting participants for clinical trial and disease monitoring,” he said. There’s more work to be done before the test makes its way to your local hospital. To start, the team needs to validate that it works for a wide variety of patients, including those who come from different ethnic backgrounds.
It’s been six years since Tesla, SpaceX (and now Twitter) CEO Elon Musk co-founded brain-control interfaces (BCI) startup, Neuralink. It’s been three years since the company first demonstrated its “sewing machine-like” implantation robot, two years since the company stuck its technology into the heads of pigs — and just over 19 months since they did the same to primates, an effort that allegedly killed 15 out of 23 test subjects. After a month-long delay in October, Neuralink held its third “show and tell” event on Wednesday where CEO Elon Musk announced, "we think probably in about six months, we should be able to have a Neuralink installed in a human."
Neuralink has seen tumultuous times in the previous April 2021 status update: The company’s co-founder, Max Hodak, quietly quit just after that event, though he said was still a “huge cheerleader” for Neuralink’s success. That show of confidence was subsequently shattered this past August after Musk reportedly approached Neuralink’s main rival, Synchron, as an investment opportunity.
Earlier in February, Neuralink confirmed that monkeys had died during prototype testing of its BCI implants at the University of California, Davis Primate Center but rejected accusations by the Physicians Committee for Responsible Medicine of animal cruelty. In July, Synchron beat Neuralink to market when doctors at Mount Sinai Hospital in New York successfully installed the company's inch-and-a-half long device into a person living with ALS. The patient, who has lost their ability to move and communicated independently, should be able to surf the web and send text messages using the device to translate their thoughts into computer commands. That same month, an affair Musk had with a Neuralink executive, who is now pregnant with his twins, also came to light.
Neuralink is still working towards gaining FDA approval for its implant, though the company was awarded the agency's Breakthrough Device Designation in July 2020. This program allows patients and caregivers more "timely access" to promising treatments and medical devices by fast tracking their development and regulatory testing. As of September, 2022 the FDA has granted that designation to 728 medical devices.
The FDA has also updated its best practices guidance regarding clinical and nonclinical BCI testing in 2021. "The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access," the agency asserted in its May guidance. "Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life."
“In many ways it’s like a Fitbit in your skull, with tiny wires,” Musk said of Neuralink's device during the 2021 livestream event. The device relies on as many as 1,024, 5-micron diameter leads "sewn" into a patient's grey matter to form connections with the surrounding neurons, providing high-resolution sampling of the brain's electrical emissions and translating between analog electrical impulses and digital computer code. Theoretically, at least. So far, all Neuralink has accomplished is getting a monkey to play Pong without a joystick.
“We hope to have this in our first humans, which will be people that have severe spinal cord injuries like tetraplegics, quadriplegics, next year, pending FDA [Food and Drug Administration] approval,” Musk told the Wall Street Journal’s CEO Council summit in January.
The European Space Agency on Wednesday selected the world’s first astronaut with a disability. John McFall, whose right leg was amputated at age 19, is the first recruit for a new program investigating accommodations for astronauts with disabilities.
The agency called for applications in March 2021, seeking people with disabilities who could pass stringent physical and psychological testing but were limited by a lack of hardware accommodations. The program will investigate the changes and costs required to send astronauts with disabilities into space. The ESA chose McFall out of 257 entrants, and describes him as the world’s first “parastronaut.” And next spring, he will enter the 12-month training program at the European Astronaut Centre in Cologne, Germany.
“I’ve always been hugely interested in science generally, and space exploration has always been on my radar,” said the 41-year-old McFall on Wednesday. “But having had a motorcycle accident when I was 19, like wanting to join the armed forces, having a disability was always a contraindication to doing that.”
After McFall’s accident and amputation, he learned to run again and won a bronze medal in the 100-meter dash at the 2008 Paralympic Games. In addition, he earned several medical degrees and was a Foundation Doctor in the British National Health Service from 2014 to 2016. McFall currently works as a trauma and orthopedic specialist in South England.
“In early 2021 when the advert for an astronaut with a physical disability came out,” said McFall, “I read the person specifications and what it entailed, and I thought, ‘Wow, this is such a huge and interesting opportunity.’ And I thought that I would be a very good candidate to help ESA answer the question they were asking: ‘Can we get someone with a physical disability into space?’ And I felt compelled to apply.”