Posts with «health care industry» label

Wearable ultrasound patch could offer real-time heart scans on the go

Ultrasound can provide detailed images of your heart, but the bulk makes it impractical for continuous scanning — especially outside of the hospital. It might be far more portable in the future, however. Researchers have developed a wearable ultrasound patch that provides real-time heart imagery, even while you're in motion. It also uses deep learning to automatically calculate ventricle volume and generate performance stats. You'd know your cardiac output at any given moment, for instance.

The device uses piezoelectric (that is, pressure-powered) transducers to perform deep tissue imaging. Stretchable liquid metal electrodes, meanwhile, ensures the ultrasound imager can stay close to your skin while remaining compact. Past attempts at wearable ultrasound arrays have relied on thin metal films that limits the design's complexity.

The technology isn't close to production. Scientists want to continue miniaturizing the system, which still needs to attach to an external processing system through a flexible cable. The team also hopes to improve the spatial resolution through better algorithms, and use a larger AI training dataset that could better reflect the general population.

Some of the advantages are already clear, mind you. The creators believe the wearable ultrasound could provide continuous metrics for patients with heart disease or in critical care, including outpatients. Remote ultrasound scans have been envisioned before, but have frequently relied on wands or other cumbersome gadgets. The tech could also be helpful for athletes hoping to strengthen their hearts and optimize their abilities.

The concept isn't limited to one organ, either. The designers say their wearable ultrasound system could be generalized for use with the spine, liver and veins. In that light, the tech could provide freedom to many patients and athletes who'd otherwise need to visit clinics or hospitals to share data for their conditions.

Amazon's RxPass offers Prime members generic medications for $5 a month

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. 

FTC asks court to hold Martin Shkreli in contempt for launching new drug company

Martin Shkreli, whom you may know as "Pharma Bro," launched a new company last year called "Druglike, Inc." Now, the Federal Trade Commission (FTC) has asked a federal judge to hold him in contempt for failing to cooperate with the agency in its investigation to determine whether launching the company violates his lifetime industry ban. US District Court Judge Denise Cote imposed a lifetime ban on Shkreli that prohibits him from participating in the pharmaceutical industry early last year. Cote ruled that the former pharma exec orchestrated an illegal anticompetitive scheme to gain a monopoly over Daraprim, a life-saving anti-malarial and anti-parasitic drug. 

After Shkreli's former company, Turing Pharmaceuticals, obtained the manufacturing license for Daraprim, it raised the drug's prices from $17.50 to $750 per tablet. Cote sided with the FTC in the antitrust lawsuit the agency filed against Shkreli in 2020 and ordered him to pay $64.6 million in damages, in addition to imposing a lifetime industry ban against him. Prior to Druglike's launch, Shkreli tried (and failed) to convince a judge to put the ban on hold, arguing that the public could benefit from his future contributions to the industry. Shkreli challenged the ban while he was serving time in federal prison after receiving a seven-year sentence in 2017 for defrauding investors. He was released from prison in May.

The FTC said it started asking Shkreli for a compliance report and access to relevant records, as well as asking him to sit for an interview regarding Druglike, in October 2022. However, the company co-founder kept on disregarding its "repeated requests." The agency also said that Shkreli has yet to pay any amount of his $64.6 million fine. It's now asking the court to order Shkreli to comply with its information requests within 21 days of its decision. 

In a press release (PDF) for its launch, Druglike described itself as "a Web3 drug discovery software platform." The company said it's building a "decentralized computing network" that "provides resources for anyone looking to start or contribute to early-stage drug discovery projects." In a statement, Shkreli said "Druglike will remove barriers to early-stage drug discovery, increase innovation and allow a broader group of contributors to share the rewards."

Meta Quest now syncs workouts with Android phones and pairs with heart-rate trackers

In a 2022 report about VR fitness, The Washington Post cited a Forrester research that said 25 percent of American adults online are interested in buying a VR headset and 18 percent think they'd primarily use it for exercise. VR fitness is a growing space, and Meta has rolled out a couple of new health-related features for its Quest headset that could convince even more people to give it a try. In its latest update for the device, the company has rolled out Health Connect integration for Android users, and, as The Verge reports, the ability to pair Bluetooth heart rate monitors with it. 

A Meta spokesperson told the publication that if paired with a compatible heart rate monitor, the Meta Quest Move overlay can display a user's heart rate on any game or app, alongside minutes exercised and calories burned. At the moment, the only known compatible monitors are the Garmin HRM-Dual and the Polar H10 chest straps, but other brands and models (even smartwatches) may be able to pair with the headset. Meta just can't confirm if they'll work with the Quest as it intended. 

Meanwhile, Health Connect integration will give users the capability to automatically sync VR workouts with their Android device. Meta first made people's VR fitness stats viewable outside of their headsets when it gave iOS users the capability to sync their progress with Apple Health last year. Now, Android users can finally see their progress without having to put on the Quest, as well. 

The Health Connect API enables health and fitness data sharing across devices and between apps, such as Samsung Health and MyFitnessPal. To activate the integration, users will first have to sync their Meta Quest Move stats with the Meta Quest mobile app. They can do so by going into the Move app in VR and clicking Settings. Users will then have to toggle on "Health Connect by Android" under the Connected Apps section inside the Meta Quest mobile app.

It's unclear if these features are also making their way to the first Quest model released under the Oculus branding. A few days ago, the company sent out emails to Quest 1 owners, telling them that their devices will no longer be getting new features going forward. Meta will also only be releasing critical security and bug patches for the device until 2024. 

There was a lot of pee on the CES 2023 show floor

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.

Withings' $500 toilet computer wants to be WebMD for your pee

Withings has already made a name for itself as a maker of smart scales and ultra-stylish activity trackers. Now, the French health-tech company is making a foray into the world of medical analysis, building a device to scan people’s urine. It’s initially intended as a way of supporting decentralized clinical trials, the company hopes to offer it as a consumer health-tech device in the future. Say hello to U-Scan.

U-Scan is a pebble-shaped device that hangs from a plastic tab on the side of your toilet bowl, much like a deodorizer block. The hardware, 90mm in diameter, is intended to sit on the porcelain where most people’s pee streams would land. There’s a collection inlet at the lowest point, and a sensor will detect the presence of urine and trigger a pump you pull a small quantity into its body. From there, the sample is pumped into a microfluidic system which triggers a chemical reaction.

Sitting underneath the U-Scan itself will be a cartridge, which contains the specific test that you’re looking for. The company has, so far, partnered with two medical centers in Europe to explore ways of discovering renal lithiasis and bladder cancer. It’s hoped that the system will eventually be used to mass-screen for cancer markers and support medical studies.

In terms of the consumer units, the company has developed U-Scan Cycle Sync, designed to be used for period tracking. The idea is to provide detailed, regular testing to enable fine-grain cycle tracking without the need for calendar apps. As well as predicting your menstrual cycle, the system says it’ll predict your ovulation window, hydration levels and nutrient levels.

The other is U-Scan Nutri Balance, which offers a “detailed metabolic guide to hydration and nutrition.” This will look at your water balance, nutrient levels, fat metabolism and quantities of vitamin C found in your pee. Most crucially, you'll be able to monitor your ketone levels, as well as the pH of your urine, good for determining if you’re eating a healthy enough diet.

When processed, the results of the tests are shared to a server over WiFi or Bluetooth, and then the cartridge will reset with a fresh test pod. The company says that U-Scan is sufficiently smart to distinguish different users, such as various family members in a home, and separate tests accordingly.

Withings has also said that its system conforms to the highest security standards, and that its data will always be held in France, in a GDPR-compliant setup. It says that U-Scan will run for three months before needing a recharge (over USB-C) and a replacement cartridge.

In terms of pricing, and availability, you’ll expect that whatever date Withings says, it may be delayed due to regulatory approvals. The company says that U-Scan will be first made available in Europe at some point in Q2, 2023, with the Nutri Balance and Cycle Sync cartridges. A starter kit, with one reader and cartridge, will be priced at €499.95 ($530), while replacement cartridges are expected to cost €30 ($31). A US release will take place at some point afterward, whenever the FDA decides to clear the product for consumer use.

Test your pee where you pee with this oversized toilet clip-on

We often see a bunch of healthcare-oriented gadgets coming out of CES, but Vivoo's latest offering isn't exactly a fitness tracker. The company has unveiled a smart toilet device that can test your urine and send the results to your phone.

The tech is built into a device that can clip onto existing toilets. Vivoo, which has offered at-home urine tests for the last few years, designed the system with residential care, the elderly and healthcare service providers in mind. It could give those who simply want to know more about what's going on with their body some additional data. 

The device will automatically align a testing strip with a person's urine stream, according to Vivoo, which says this approach should reduce the risk of mess involved with a handheld strip. An optical reader akin to those used in hospitals analyzes the urine sample for four wellness parameters and delivers the results to the Vivoo app within 90 seconds. The company suggests that the results can offer "indications of certain deficiencies or abnormalities" and help with early detection of some conditions.

Vivoo says its app can provide data on your body's water, magnesium, pH, protein and sodium levels, among others, though disclaimers on its website say these measurements are not intended for medical use. It offers nutrition advice based on the results and Vivoo may suggest personalized supplements.

The company claims it's easy to clean the smart toilet device. It adds that the system has an ergonomic design. However, based on images Vivoo provided, the device is positioned at the front of the toilet seat and it looks fairly cumbersome. Folks who need to sit to pee may find it difficult to position their legs around it, such as the elderly and those with mobility issues.

Researchers develop blood test that can reliably detect Alzheimer’s disease

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.

Movano takes on Oura with the Evie smart ring designed 'for women'

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 and other health-tracking wearables, though the company says it's "designed uniquely for women." Movano plans to provide a closer look next week at CES 2023.

The ring made its debut at CES 2022 with no name and a similar design, but Movano has since changed course on price and other factors. It will sell the ring sometime in 2023 at a one-time price below $300 (there's no exact date or price yet), rather than using a subscription model as it said last year. 

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. Wearers will can get advice from health experts inside the app and it will meet medical device manufacturing standards, the company promised.

"As a medical device, Evie will go beyond the status quo of other wearables on the market," said Movano CEO John Mastrototaro. "We are bringing together medical grade biometric data and insights in a comfortable and contemporary wearable."

With the ability to measure steps, calories burned and specific activities, Evie can also be used as a fitness tracker. However, it's primary purpose is to give a picture of overall health, "turning biometric data into actionable insights," Movano wrote in the press release.

The company also promises security and privacy when transferring data to the cloud or health providers. It's currently seeking all-important FDA clearance, which will dictate the release date. If that takes too long, though, it may come to market as a wellness device at first. The Evie smart ring will only be released in the US to start with, but may come to other markets later — we should learn more about it next week at CES 2023. 

Neuralink CEO Elon Musk expects human trials within six months

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. 

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