A company that makes an implantable brain-computer interface (BCI) has been given the go-ahead by the Food and Drug Administration to run a clinical trial with human patients. Synchron plans to start an early feasibility study of its Stentrode implant later this year at Mount Sinai Hospital, New York with six subjects. The company said it will assess the device's "safety and efficacy in patients with severe paralysis."
Synchron received the FDA's green light ahead of competitors like Elon Musk’s Neuralink. Before such companies can sell BCIs commercially in the US, they need to prove that the devices work and are safe. The FDA will provide guidance for trials of BCI devices for patients with paralysis or amputation during a webinar on Thursday.
Another clinical trial of Stentrode is underway in Australia. Four patients have received the implant, which is being used "for data transfer from motor cortex to control digital devices," Synchron said. According to data published in the Journal of NeuroInterventional Surgery, two of the patients were able to control their computer with their thoughts. They completed work-related tasks, sent text messages and emails and did online banking and shopping.
It takes around two hours to implant a Stentrode device with a minimally invasive procedure, according to Synchron. The device is implanted through a blood vessel at the bottom of the neck and maneuvered into the brain. Synchron CEO Thomas Oxley told Bloomberg the device could be available to buy within three to five years.
We've seen helmets and AI that can spot brain tumors, but a new hard hat can actually treat them, too. As part of the latest neurological breakthrough, researchers used a helmet that generates a magnetic field to shrink a deadly tumor by a third. The 53-year-old patient who underwent the treatment ultimately passed away due to an unrelated injury. But, an autopsy of his brain showed that the procedure had removed 31 percent of the tumor mass in a short time. The test marked the first noninvasive therapy for a deadly form of brain cancer known as glioblastoma.
The helmet features three rotating magnets connected to a microprocessor-based electronic controller operated by a rechargeable battery. As part of the therapy, the patient wore the device for five weeks at a clinic and then at home with the help of his wife. The resulting magnetic field therapy created by the helmet was administered for two hours initially and then ramped up to a maximum of six hours per day. During the period, the patient's tumor mass and volume shrunk by nearly a third, with shrinkage appearing to correlate with the treatment dose.
The inventors of the device — which received FDA approval for compassionate use treatment — claim it could one day help treat brain cancer without radiation or chemotherapy. “Our results...open a new world of non-invasive and nontoxic therapy...with many exciting possibilities for the future,” said David S. Baskin, corresponding author and director of the Kenneth R. Peak Center for Brain and Pituitary Tumor Treatment in the Department of Neurosurgery at Houston Methodist Neurological Institute. Details of the procedure have been published in the peer-reviewed journal Frontiers in Oncology.
Foxconn and TSMC are solving a political drama even as they serve their own tech manufacturing interests. The Wall Street Journalreports that the two companies have agreed to buy 10 million Pfizer/BioNTech COVID-19 vaccine doses on behalf of Taiwan's government. The two are purchasing the shots from Fosun Pharmaceutical after China allegedly "spiked" Taiwan's bid to directly buy the vaccine.
There was pressure to make a deal. Taiwan has largely kept COVID-19 levels low throughout the pandemic, but new cases started surging in late April and prompted rare restrictions on the island. While infections are dropping, Taiwan has only vaccinated about 14 percent of its population. It will need many more doses if it's going to lift restrictions while keeping cases low.
Tech companies like have offered to buy vaccines for employees and contractors before. Apple helped TSMC buy vaccines for its staff, for instance. A purchase this large for the general population breaks new ground, however — the companies are buying enough doses to inject over 40 percent of Taiwan's 24 million people.
Foxconn and TSMC have strong incentives to step in. Outbreaks could hurt their operations, even for those factories and other facilities beyond Taiwan. That could be particularly dangerous amid a global chip shortage and other manufacturing headaches — mass infections and shutdowns could cause further snarls. A vaccine purchase like this could save the companies money in the long run.
Moderna has injected its mRNA-derived vaccine for the seasonal flu into a human volunteer for the first time as part of a Phase 1/2 clinical study, the company announced on Wednesday.
This is a very early test for the new vaccine technology, geared primarily towards building a baseline understanding of the treatment's "safety, reactogenicity and immunogenicity," according to a Moderna release. mRNA-1010, as the vaccine has been dubbed, is designed to be effective against the four most common strains of the virus including, A H1N1, H3N2, influenza B Yamagata and influenza B Victoria. According to the World Health Organization, these strains cause between 3 and 5 million severe cases of flu every year, resulting in as many as 650,000 flu-related respiratory deaths annually. In the US alone, roughly 8 percent of the population comes down with the flu every winter. The company hopes this vaccine will prove more potent than the current 40 - 60 percent efficacy rate of conventional flu vaccines.
“We are pleased to have begun this Phase 1/2 study of mRNA-1010, our first mRNA seasonal flu vaccine candidate to enter the clinic. We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines,” Stéphane Bancel, Moderna's CEO said. “Respiratory combination vaccines are an important pillar of our overall mRNA vaccine strategy. We believe that the advantages of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to rapidly respond to the evolution of respiratory viruses, such as influenza, SARS-CoV-2 and RSV. Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses."
This vaccine has been generated using the same genomic techniques the company utilized to develop its COVID-19 treatment in 2020. The technique works by exploiting the human body's own cells to reproduce snippets of viral DNA to instigate an immune response and prime the body against future infection. Since this method doesn't require the entire virus (either weakened or dead) but rather just a birt of its genetic code, mRNA vaccines could be applied to any number of deadly modern diseases including malaria, TB — even cancer.
Amazon took a different approach from companies like Apple, Google and Samsung when it launched its first health-centric wearable last year. The Halo band stood out as a screenless $100 wrist-band that required a monthly subscription for the bulk of its functions, and kicked up a ton of controversy with its tone-detecting feature. The company is continuing to deviate from industry trends like squeezing more sensors or adding more workout types and is instead rolling out a smartphone camera-driven service called Movement Health, which it announced earlier this month.
Movement Health is another way Amazon is distinguishing itself from the sea of other fitness offerings. Instead of just tracking your steps, heart rate and sleep, which the Halo wearable does, the app also offers tools like body fat scanning and tone detecting. The latter feature was widely denounced at launch for listening in on all your conversations all the time. Even setting aside those concerns, Tone Detection isn’t very useful anyway — Amazon doesn’t provide enough context around each entry to help you understand why you sounded “angry” or “happy” at various points during the day.
Amazon Halo general features
But as someone who’s been trying to improve her general fitness and knows that weight is only one of many metrics towards an overall picture of your health, I’ve found the body fat scan helpful. As a recap, Amazon uses your phone’s camera to take front, back and side pictures of you, then analyzes it to deduce your body fat percentage. The company has cited study after study claiming its computer vision tool is more accurate than scales using bioimpedance, which send a mild electric current through your body. Pennington Biomedical Research Center even goes as far as to say that its tests found the Halo app “can be as accurate as the methods doctors use to measure body fat percentage.” That study, by the way, was funded by Amazon.
In my own experience with the band over the last few months, Halo's greatest draw is its app. The device itself, which doesn’t have a screen, is nondescript and underwhelming. It’s so plain that I didn’t even notice it was on a pile of laundry one day and accidentally tossed it into my washing machine. The good thing is that it survived being washed and dried. This might be the Nokia 3310 of wearables.
Just like the old-school phone, the Halo band doesn’t do much. It houses a heart rate monitor and microphones to track your heart rate and tone (if you opt in). It also has an accelerometer to help it log your steps and sleep, as well as a multi-function button. There’s nothing wrong with a simple device that just does the basics, except that it costs $100. You could get all these features for a fraction of the price from a plethora of companies without having to pay an additional monthly subscription fee.
Movement Health impressions and testing
Where Amazon does stand out is in offerings like body fat scanning and Movement Health. The latter, which rolls out today, is intended to “improve the way you move.” I don’t like the idea that there’s something inherently wrong about the way some people move, but if you’ve ever wondered whether your joints might be stiffer than most, or you’ve had issues with back or shoulder pain, Movement Health might help. According to Amazon, it’s “based on functional fitness, which is your body’s readiness to execute the everyday movements you do without thinking — bending, reaching, lifting, twisting, pulling, pushing and even just walking.”
Basically, the Halo app can guide you through a quick mobility test, and through your phone camera it’ll assess your performance. I've had it for just under two weeks. On my first attempt, I ran the test on my Pixel 4a, and per the app’s directions I turned my speaker volume up and set the phone on the ground leaning against a wall. It also suggested I wear form fitting clothes and tie my hair up. Once I framed myself within the outlined boundaries, the app showed an instructor that demonstrated each movement. I’d recommend using wireless headphones if you can for this part, as I struggled to hear the instructions over street noise in an apartment in Brooklyn.
The entire session was about 10 minutes long and Halo asked me to do sets of five movements like squats, lunges and overhead reaches — both facing the camera and to the side. Each time I successfully performed an action, it chimed and told me to repeat the action (when required). At the end, I got a report saying my performance was “great, you’re in the healthy range!” I scored 94 percent on Mobility and Stability, and 93 percent on Posture.
Results and recommended exercises
The app also displayed cards on each metric, explaining what they meant and how they related to my physiological performance. Scrolling further down, I also saw a detailed breakdown of things like “shoulder mobility,” “trunk stability,” “hip mobility,” “hip stability,” “lower mobility” and more. According to Amazon, “this assessment delivers comparable accuracy to an in-person assessment with a professional trainer.” I’ve yet to have a similar assessment with a professional trainer so I can’t vouch for that claim.
Amazon Halo app screenshots
Like the body fat scan tool and other Halo features, by the way, Amazon says “multiple layers of privacy and security are built into the service to keep data safe and in your control.” The assessment videos of you lunging and squatting are “encrypted in transit to the cloud, securely processed within seconds and then automatically deleted.” The company promises that no one ever sees them, whether or not you take Amazon at its word is your decision.
After analyzing your results, you can also check out the program of “corrective exercises” that Amazon recommends based on your performance. For me, the system suggested two sets of actions like 45 seconds of shinbox bridge extensions, 60 seconds of side lying t-spine rotation and 40 seconds of hip airplanes, for example. I’m meant to alternate these and do them at least three days a week for four weeks. Each set has a video led by physical therapist Dr. Kelly Starrett, as well as text laying out the movements. In the videos, Dr. Starrett explained not just how to perform each movement but also what areas it targets and how it helps your general mobility.
You can set up a schedule and reminders to have Amazon keep you on track via notifications on your phone. The company also recommends that you perform an assessment every two to four weeks, which will likely result in new sets of corrective exercises for you to use. Amazon says “if you’re looking for a little extra burn, you can also see an additional curated list of workout recommendations to provide a higher-intensity alternative.”
Wrap-up
As someone who hits the gym or yoga mat three to four times a week, I didn’t see the need to add these exercises to my routine. Most of the moves are similar to what I get out of my yoga sessions. But if you’re plagued by joint or back issues, these videos might be a good, gentle way to start working on your mobility in those areas. Of course, this shouldn’t and can’t replace a visit to the doctor, but they could be a helpful supplement. So far, Movement Health and the body fat scans seem to be ways Amazon is trying to use its computer vision skills to improve the Halo app, making it much more useful than the band on its own. Too bad having the device tied to your account is a requirement.