Researchers have developed a promising synthetic heart valve that may eventually be used for growing children. Harvard’s Wass Institute and John A. Paulson School of Engineering and Applied Sciences (SEAS) created what they call FibraValve. This implant can be manufactured in minutes using a spun-fiber method that lets them shape the valve’s delicate flaps on a microscopic level — ready to be colonized by the patient’s living cells, developing with them as they mature.

FibraValve is a follow-up to JetValve, the team’s 2017 artificial heart valve that employed many of the same principles. The updated version uses “focused rotary jet spinning,” which adds streams of focused air to more quickly and accurately collect synthetic fibers on a spinning mandrel — making it easier to fine-tune the valve’s shape. As a result, the polymer’s micro- and nano-fibers can more precisely replicate the tissue structure of an organic heart valve. The manufacturing process takes less than 10 minutes; alternative methods can require hours.

Wyss Institute at Harvard University

The technique also uses “a new, custom polymer material” called PLCL (a combination of polycaprolactone and polylactic acid) that can last inside a patient’s body for about six months — enough time (in theory) for the patient’s cells to infiltrate the structure and take over. Although it’s only been successfully tested in sheep so far, the long-term vision is for the resulting organic tissue to develop with human children as they mature, potentially voiding the need for risky replacement surgeries as their bodies grow. “Our goal is for the patient’s native cells to use the device as a blueprint to regenerate their own living valve tissue,” said corresponding author Kevin “Kit” Parker.

In the researchers’ test on a living sheep, the FibraValve “started to function immediately, its leaflets opening and closing to let blood flow through with every heartbeat.” Additionally, they observed red and white blood cells and fibrin protein collecting on the valve’s scaffolding within the first hour. The scientists say the synthetic valve showed no signs of damage or other problems. “This approach to heart valve replacement might open the door towards customized medical implants that regenerate and grow with the patient, making children’s lives better,” said co-author Michael Peters.

The research is still preliminary, and the team plans to conduct longer-term animal testing over weeks and months for further evaluation. However, they believe their breakthrough could eventually find other uses, including creating different valves, cardiac patches and blood vessels. You can read the entire paper on Matter.

Ingestible video capsule endoscopes have been around for a while, but they’re severely limited and not controllable by physicians, relying entirely on gravity and the digestive system for movement. Researchers may have just gotten around that limitation by developing a pill-shaped capsule that allows for remote control, as announced by the GW School of Medicine & Health Sciences.

This tech lets physicians quite literally drive a miniature video capsule, called the NaviCam, throughout the digestive system to visualize and photograph potential problem areas, offering a potential alternative to the traditional endoscopy. It uses an external magnet and video game style joysticks for movement.

“A traditional endoscopy is an invasive procedure for patients, not to mention it is costly due to the need for anesthesia and time off work,” Andrew Meltzer, a professor of Emergency Medicine at the GW School of Medicine & Health Sciences, said. “Magnetically controlled capsules could be used as a quick and easy way to screen for health problems in the upper GI tract such as ulcers or stomach cancer.”

This technology is still in the testing phase though results have been positive. Meltzer and colleagues at medical technology company AnX Robotica conducted a 40-person study and found that doctors could accurately control the capsule to all major parts of the stomach with a 95 percent rate of successful visualization. These patients also underwent a traditional endoscopy to confirm that the camera didn’t miss any high-risk lesions.

The potential benefits for patients are varied, as the camera’s designed to pick up bleeding, inflammation, and lesions. It can also automatically transmit videos and images off-site for further review. The official study indicates that using a camera capsule offers no health risks, though the tech doesn’t allow for biopsies, as it degrades inside of the body. Researchers note this pilot testing program is still in the beginning stages and a “much bigger trial with more patients” is on the horizon.

The makers of an app called Sleep Reset claim it can help you get more (and better) sleep without the use of drugs — and they have the study to prove it. A group of researchers from the University of Arizona's Sleep and Health Research Program, some of whom also serve as the company's medical advisors, have just published a paper in peer-reviewed journal Frontiers in Sleep. The paper details the results of a 12-week program that used Sleep Reset, which apparently increased the average participant's sleep time by 44 minutes.

Those who were getting less than six hours of sleep a night increased their sleep time by 85 minutes. Some of them likely improved their time because they were able to fall asleep much earlier: The paper says participants who typically lie awake for 30 minutes before dozing off managed to reduce that time by 53 percent. And those who usually spend an hour trying to fall asleep were able to reduce their time awake by 41 percent. Meanwhile, those'd wake up more than three times overnight found themselves experiencing two fewer nightly awakenings. The researchers also said that nearly half of the participants stopped using sleep aids after completing the program.

The study involved 564 participants (65 percent of whom were female) aged 30 to 60 years old who followed a standardized curriculum for three months. They used Sleep Reset in the way it's meant to be used in that its sleep coaches gave them personalized recommendations and feedback via text messages within the app. They also used the app's sleep diary, mindfulness exercises and trackers to monitor their progress. To use Sleep Reset, a user needs to answer a series of questions on what kind of sleep they're getting and what they're having trouble with. They're also asked to state what their goals are, such as whether they're looking to feel more well-rested or to look more youthful.

I tried the sleep assessment test and was told repeatedly throughout that Sleep Reset is effective because it "uses the same scientifically proven methods that are used by top tier Sleep Clinics like Stanford and Mayo Clinic." It also said that Sleep Reset uses "scientific strategies," such as techniques based on cognitive behavioral therapy for insomnia, and coaches users about behavioral scheduling, light exposure and relaxation. I only got so far as the page charging me for a seven-day trial period, which users could get for as little as $9 to as much as $29. The most expensive option, the company said, will help it support those who could only afford to pay the minimum amount.

That said, the participants' curriculum gives us a good look at how Sleep Reset can help support its users. Every week, they received different types of coaching tips. During week three, for instance, they got napping strategies and tips on caffeine intake, while they received information on how nutrition and physical movement affect sleep quality during week six. While there was a theme for each week, the participants presumably received information that's tailored for each of them. 

Dr. Michael Grandner, Associate Professor of Psychiatry at the University of Arizona College of Medicine and Sleep Reset's Lead Scientific advisor said: "Many popular sleep solutions like Trazadone, Benadryl and Melatonin don't even have the clinical evidence to increase total sleep time much at all. Ambien and Lunesta are known to increase sleep time by around 30 minutes, but that's much less than what we've seen from Sleep Reset. What's even better is that Sleep Reset is a non-medication intervention, thus non-habit forming and devoid of troubling side effects."

You can watch Dr. Grandner talk about their study below:

Ever year, more than a million people in North America suffer some form of spinal cord injury (SCI), with an annual cost of more than $7 billion to treat and rehabilitate those patients. The medical community has made incredible gains toward mitigating, if not reversing, the effects of paralysis in the last quarter-century including advances in pharmacology, stem cell technologies, neuromodulation, and external prosthetics. Electrical stimulation of the spinal cord has already shown especially promising results in helping spinal injury patients rehabilitate, improving not just extremity function but spasticity, bladder and blood pressure control as well. Now, in a study published in Nature Tuesday, SCI therapy startup Onward Medical, announced that it has helped improve a formerly-paraplegic man’s walking gait through the use of an implanted brain computer interface (BCI) and novel “digital bridge” that spans the gap where the spine was severed.

We’ve been zapping paraplegic patients’ spines with low-voltage jolts as part of their physical rehabilitation for years in a process known as Functional Electrical Stimulation (FES). Electrodes are placed directly over the nerves they’re intended to incite – externally bypassing their own disrupted neural pathways – and, when activated, cause the nerves underneath to fire and their muscles contract. Researchers have used this method to restore hand and arm motion in some patients, the ability to stand and walk in others and, for a lucky few, exosuits! The resulting limb motions however were decidedly ungraceful, resulting in ponderous arm movements and walking gaits that more resembled shuffles.

Onward’s earlier research into epidural electrical stimulation showed that it was effective at targeting nerves in the lower back that could be used to trigger leg muscles. But the therapy at that time was hampered by the need for wearable motion sensors, and by, “the participants … limited ability to adapt leg movements to changing terrain and volitional demands.“ Onward addressed that issue in Tuesday’s study by incorporating a “digital bridge” to monitor the brain’s command impulses and deliver them, wirelessly and in real-time, to a stimulation pack implanted in the patient’s lower back.

Clinicians have employed these systems for the better part of a decade to assist in improving upper extremity control and function following SCI – Onward’s own ARC EX system is designed to do just that – though this study was the first to apply the same theories to the lower extremities.

Onward’s patient was a 38-year-old man who had suffered an “incomplete cervical (C5/C6) spinal cord injury” a decade before and who had undergone a five-month neurorehabilitation program with “targeted epidural electrical stimulation of the spinal cord” in 2017. “This program enabled him to regain the ability to step with the help of a front-wheel walker,” the research team noted in the Nature study. “Despite continued use of the stimulation at home, for approximately three years, he had reached a neurological recovery plateau.”

In addition to the EX, Onward Medical has also developed an internally mounted electrostimulation therapy, the ARC IM. Per the company, it is”purpose-built for placement along the spinal cord to stimulate the dorsal roots,” to help improve SCI patients’ blood pressure regulation. The system used in Tuesday’s study used the ARC IM as a base and married it to a WIMAGINE brain computer interface.

Onward Medical

The Onward team had to first install the BCI inside the patient's skull. Technically, it was a pair of 64-lead electrode implants, each mounted in a 50-milimenter circular-shaped titanium case that sits flush with the skull. The WIMAGINE “is less invasive than other options while offering sufficient resolution to drive walking,” Dave Marver, OnwardMedical CEO, told Engadget via email. “It also has five-year data that demonstrates stability in the clarity of signals produced.”

Two external antennas sit on the scalp, the first providing power to the implants via inductive coupling, the second to shunt the signal to a portable base station for decoding and processing. The processed signal is then beamed wirelessly to the ACTIVA RC implantable pulse generator sitting atop the patient’s lumbar region where 16 more implanted electrodes shock the appropriate nerve clusters to move their legs. Together they form a Brain Spine Interface (BSI) system, per Onward.

The entire setup is designed to be used independently by the patient. The assistive walker houses all the BSI bits and pieces while a tactile feedback interface helps them correctly position the headset and calibrate the predictive algorithm.

In order to get the BCI and pulse generator to work together seamlessly, Onward leveraged a “Aksenova/Markov-switching multilinear algorithm that linked ECoG signals to the control of epidural electrical stimulation parameters,” which seems so obvious in hindsight. Basically, this algorithm predicts two things: the probability that the patient intends to move a specific joint based on the signals it’s monitoring, and both the amplitude and direction of that presumed intended movement. Those predictions are then dumped into an analog controller which translates them into code commands that are, in turn, cycled to the pulse generator every 300 milliseconds. In all, the latency between the patient thinking, “I should walk over there,” and the system decoding those thoughts is just 1.1 seconds.

Calibrating the system to the patient proved an equally quick process. The patient had figured out how to properly “activate” the muscles in their hips to generate enough torque to swing their legs within the first two minutes of trying — and did it with 97 percent accuracy. Over the course of the rehabilitation, the patient managed to achieve control over the movements of each joint in their leg (hip, knee and ankle) with an average accuracy (in that the BSI did what the patient intended) of around 75 percent.

“After only 5 min of calibration, the BSI supported continuous control over the activity of hip flexor muscles,” the team continued, “which enabled the participant to achieve a fivefold increase in muscle activity compared to attempts without the BSI” Unfortunately, those gains were wiped away as soon as the BCI was turned off, instantly losing the ability to step, they explained. “Walking resumed as soon as the BSI was turned back on.”

It wasn’t just that the patient was able to graduate from walking with a front-wheeled frame walker to crutches thanks to this procedure – their walking gait improved significantly as well. “Compared to stimulation alone, the BSI enabled walking with gait features that were markedly closer to those quantified in healthy individuals,” the Onward team wrote. The patient was even able to use the system to cross unpaved terrain while on their crutches, a feat that still routinely proves hazardous for many bipedal robots.

In all, the patient underwent 40 rehab sessions with the BCI – a mix of standard physio-rehab along with BCI-enabled balance, walking and movement exercises. The patient saw moderate gains in their sensory (light touch) scores but a whopping 10-point increase in their WISCI II scores. WISCI II is the Walking Index for Spinal Cord Injury, a 21-point scale measuring a patient’s ambulatory capacity ranging from 20, “can move zero assistance,” down to 0, “bed ridden.“ Onward’s patient went from a 6 to a 16 with the help of this therapy.

“As the participant had previously reached a plateau of recovery after intensive rehabilitation using spinal cord stimulation alone, it is reasonable to assume that the BSI triggered a reorganization of neuronal pathways that was responsible for the additional neurological recovery,” the Onward team wrote. “These results suggest that establishing a continuous link between the brain and spinal cord promotes the reorganization of residual neuronal pathways that link these two regions under normal physiological.”

While the results are promising, much work has yet to be done. The Onward team argues that future iterations will require “miniaturization of the base station, computing unit and unnoticeable antennas,” faster data throughputs, “versatile stimulation parameters, direct wireless control from the wearable computing unit,” and “single low-power integrated circuit embedding a neuromorphic processor with self-calibration capability that autonomously translates cortical activity into updates of stimulation programs.”

Despite the daunting technical challenges, “the BCI system described in Tuesday’s Nature publication may reach the market in five to seven years,” Marvel predicted. ”It is possible and realistic that a BCI-augmented spinal cord stimulation therapy will be on the market by the end of the decade.”

Turns out Elon Musk's FDA prediction was only off by about a month. After reportedly denying the company's overtures in March, the FDA approved Neuralink's application to begin human trials of its prototype Link brain-computer interface (BCI) on Thursday. 

Founded in 2016, Neuralink aims to commercialize BCIs in wide-ranging medical and therapeutic applications — from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic controls, to the capacity "to rewind memories or download them into robots," Neuralink CEO Elon Musk promised in 2020. BCIs essentially translate the analog electrical impulses of your brain (monitoring it using hair-thin electrodes delicately threaded into that grey matter) into the digital 1's and 0's that computers understand. Since that BCI needs to be surgically installed in a patient's noggin, the FDA — which regulates such technologies — requires that companies conduct rigorous safety testing before giving its approval for commercial use. 

In March, the FDA rejected Neuralink's application to begin human trials reportedly in part due to all the test animals that kept dying after having the prototype BCI implanted. According to internal documents acquired by Reuters in December, more than 1,500 animals had been killed in the development of the Neuralink BCI since 2018. The US Department of Agriculture's (USDA) Inspector General has since launched an investigation into those allegations.  

The FDA's reticence was also born from concerns about the design and function of the interface when implanted in humans. "The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue," current and former Neuralink employees told Reuters in March.

While Neuralink has obtained FDA approval to begin its study, the company is not yet seeking volunteers. This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people," Neuralink Tweeted on Thursday. "Recruitment is not yet open for our clinical trial."  

It can cost billions of dollars to develop drugs and a large percentage fail at the trial stage, so a number of companies are deploying AI to help in that area. Google's Cloud division is the latest to join that race with two new suites aimed at addressing drug discovery while advancing precision medicine, it announced. 

The Target and Lead Identification Suite aims to help drug companies better understand proteins and amino acids that are key to drug development. Specifically, it's designed to help scientists identify biological targets that researchers can develop treatments around. This could effectively speed up drug discovery and lower costs. 

Early adopters for the suite "include multinational pharmaceutical companies like Pfizer and industry-leading biotech companies including Cereval," Google Cloud wrote in a press release. "We are partnering with Google on exploring how AlphaFold2 can potentially accelerate our drug discovery process, speeding up our researchers' ability to conduct their experiments on Google Cloud's scalable, accelerator-optimized compute platform," said Pfizer's principal computational scientist, Nicholas Labello. 

Meanwhile, the Multiomics Suite is designed to tackle genomic data analysis. The idea is to find out how genetic variations affect disease in order to create appropriate and even personalized treatments. Genomic databases tend to be enormous, so the suite would give researchers fast access to the appropriate data, helping accelerate treatments. 

"We would not be anywhere near where we are today" without the tool, Colossal Biosciences CEO Ben Lamm told CNBC. That company has been an early adopter of Multiomics, and Lamm said it would have been a "massive burden" for Colossal to try to build something similar itself. 

One of the unpleasant technological reminders of the pandemic is fading away. States have turned off COVID-19 exposure notifications on iPhones across the US now that the public emergency has expired. At least some states also appear to be shutting down notifications for Android users. You won't get alerts if you approach someone who tested positive and reported their results. No personal data traded hands, as the system relied on anonymized Bluetooth exchanges rather than GPS.

California and other states chalk up the decision to a combination of vaccines, wide immunity and effective treatments. The risks of serious illness have declined, according to officials. Omicron variants have also been less severe than early strains. Simply put, there isn't as much need for exposure alerts.

The technology was first announced in April 2020 as Apple and Google raced to create a common approach to exposure notification in the early days of the pandemic. The initial notifications came through states' individual apps beginning in August that year, but OS updates in September brought an Exposure Notifications Express feature to many Android and iOS devices. This theoretically reduced infections by getting people to stay home in the event of possible contact.

That's not how the exposure notifications worked in practice, however. Researchers determined that the rollout was fragmented. As there wasn't a nationwide protocol early on, states either implemented their own COVID-19 alerts or delayed launches. A user from one state might not get an exposure warning if they came close to someone from another state. Only 26 states released apps to make full use of notifications, and just 36 million Americans had either installed an app or enabled Exposure Notifications Express as of May 2021. While there's evidence the tech prevented cases (Washington State's app may have prevented 5,500 cases in its first four months), most of the population wasn't sharing data.

That's not to say the exercise was pointless. California's Department of Public Health says it's still studying the benefits of the state's app, and the findings from the COVID-19 response could help deal with future diseases. Don't be surprised if health agencies and tech companies are better prepared going forward.

Samsung has unveiled its upcoming user interface for Galaxy Watches, and it comes with new health-related features, with a focus on ones designed to help you get a better quality of sleep. Its new Sleep Insights UI, for instance, now prominently displays your sleep score that's based on several metrics, such as your snoring hours and blood oxygen levels. 

That way, you can easily see why you feel tired even though you've just woken up. Or, you can take note of when you feel especially refreshed in the morning so you can try to replicate anything you did that may have contributed to the quality of sleep you got. In addition, Sleep Coaching is now available on the Watch itself, and not just on its paired phone, allowing you to track your habits more easily.

Samsung has also added a new running tool called Personalized Heart Rate Zone that analyzes your capabilities and sets five optimal workout intensity levels based on your stats and history. This enables you to set your own goals and achieve new heights when it comes to activity, as you're only competing with yourself. 

Samsung

If you like outdoor activities and have a Galaxy Watch Pro, you'll see an improved Route Workout feature that supports running and walking, not just hiking and cycling. Finally, the upcoming Watch UI will have an updated SOS feature that directly connects to an emergency number to relay your location. First responders will also be available to access your medical information when emergency mode is activated. And in case you're 55 or older, fall detection will be activated by default. 

Samsung's One UI 5 Watch will officially launch with the next-generation Galaxy Watch series later this year. However, you can register for the beta program on the Samsung Members app starting this month if you have a Watch 4 or a Watch 5 device. 

Samsung

Withings has rounded out its current lineup of smart scales with a new entry-level model. The Body Smart, which is available starting today for $100, replaces the Body+. It comes with a swathe of bells and whistles, including an Eyes Closed mode. With this enabled, Withings won't display your weight on the scale's color screen. Instead, the company's app will track your weight. Withings says that, with Eyes Closed switched on, you'll "see encouraging, motivating messages or daily information such as step counts, air quality and the weather" instead of numbers in pounds and ounces.

Other modes offered by Body Smart, which is compatible with the Withings+ subscription service, include one for athletes, one for pregnant people and another for babies. The scale supports up to eight users, so one should be enough for most households.

Withings says, as with its other models, Body Smart offers accurate and consistent weight measurements up to 50 grams. Along with weight and body composition analysis, the company says it can help you track metrics such as heart rate, visceral fat (a type of fat that surrounds internal organs) and metabolic age.

The device is able to monitor these factors thanks to multifrequency bioelectrical impedance analysis technology. This sends an electrical signal through the body to measure the resistance and reactions of body tissues to the currents. "The more frequencies used, the more complete and accurate the picture of body health can be created," Withings says.

Along with the other advanced metrics, Withings claims that, for the first time, Body Smart will be able to measure your basal metabolic rate (BMR), which monitors how many calories one burns while resting. This can provide helpful information about your metabolic health and the scale will use it to determine your metabolic age, Withings says. The company will add these features in May.

Meanwhile, Withings has upgraded the mid-tier, $200 Body Comp scale with a color LCD screen. As for the high-end Body Scan option, Withings expects that to be available in the US in the coming months after gaining Food and Drug Administration clearance. The $400 smart scale, which is already available in Europe, features segmental body composition and a six-lead electrocardiogram with atrial fibrillation detection. Unlike the other two models, the Body Scan comes with a rechargeable battery.

Researchers at Stanford Medicine have made a promising discovery that could lead to new cancer treatments in the future. Scientists conducted tests in which they altered the genomes of skin-based microbes and bacteria to fight cancer. These altered microbes were swabbed onto cancer-stricken mice and, lo and behold, tumors began to dissipate.

The bacteria in question, Staphylococcus epidermidis, was grabbed from the fur of mice and altered to produce a protein that stimulates the immune system with regard to specific tumors. The experiment seemed to be a resounding success, with the modified bacteria killing aggressive types of metastatic skin cancer after being gently applied to the fur. The results were also achieved without any noticeable inflammation.

“It seemed almost like magic,” said Michael Fischbach, PhD, an associate professor of bioengineering at Stanford. “These mice had very aggressive tumors growing on their flank, and we gave them a gentle treatment where we simply took a swab of bacteria and rubbed it on the fur of their heads.”

This is yet another foray into the misunderstood world of microbiomes and all of the bacteria that reside there. Gut biomes get all of the press these days, but the skin also plays host to millions upon millions of bacteria, fungi and viruses, and the purpose of these entities is often unknown.

In this instance, scientists found that staph epidermidis cells trigger the production of immune cells called CD8 T cells. The researchers basically hijacked the S. epidermidis into producing CD8 T cells that target specific antigens. In this case, the antigens were related to skin cancer tumors. When the cells encountered a matching tumor, they began to rapidly reproduce and shrink the mass, or extinguish it entirely.

“Watching those tumors disappear — especially at a site distant from where we applied the bacteria — was shocking,” Fischbach said. “It took us a while to believe it was happening.”

As with all burgeoning cancer treatments, there are some heavy caveats. First of all, these experiments are being conducted on mice. Humans and mice are biologically similar in many respects, but a great many treatments that work on mice are a dud with people. Stanford researchers have no idea if S. epidermidis triggers an immune response in humans, though our skin is littered with the stuff, so they may need to find a different microbe to alter. Also, this treatment is designed to treat skin cancer tumors and is applied topically. It remains to be seen if the benefits carry over to internal cancers.

With that said, the Stanford team says they expect human trials to start within the next few years, though more testing is needed on both mice and other animals before going ahead with people. Scientists hope that this treatment could eventually be pointed at all kinds of infectious diseases, in addition to cancer cells.