Researchers at Brigham and Women’s Hospital in Boston have developed an implant, notably as small as a grain of rice, that can test the effects of drugs on a patient’s brain tumor in real-time during surgery. Currently, monitoring the effects of drugs on a brain cancer patient during surgery is limited to intraoperative brain imaging and tissue sampling after a drug has been administered. The technique known as microdialysis currently stands as one of the more minimally invasive sampling options for testing the impact of drugs on brain tumors, but even that requires an entire catheter to be inserted into the patient’s skull cavity.

During development, researchers from Brigham and Women’s Hospital designed the device specifically to help test treatments in patients with brain cancers or gliomas, a type of tumor that originates in the brain or spinal cord. The device is designed to only remain implanted in a patient for about two to three hours while it delivers microdoses of the respective drug that is under observation. It can observe the impact of up to 20 drugs on the market for cancerous tumors, according to the researchers. Once the device is removed (sometime before the surgery ends), the surrounding tissue is returned to the lab for analysis.

In a statement published Wednesday, Pierpaolo Peruzzi, co-principal investigator and assistant professor in the Department of Neurosurgery at Brigham and Women’s Hospital said that knowing the impact of cancer drugs on these tumors is critical. “We need to be able to understand, early on, which drug works best for any given patient,” he said.

Brigham and Women’s Hospital

During the development process, researchers at the Brigham and Women’s Hospital ran a clinical trial to observe the actual impact of the implant on real patients. The study found that none of the patients in the trial experienced any adverse effects. The researchers were able to collect biological data from the devices, such as what molecular changes happened when each drug was administered. While the study demonstrated that the implant could be easily incorporated into surgical practice, the researchers are still determining how the data it can gather should be used to optimize tumor therapy.

The researchers are now conducting another study that focuses on implanting the device through a minimally invasive procedure 72 hours before their main surgery. Advancements in the cancer treatment space continue to expand, with new iterations of drug cocktails and viruses that can fight cancer cells emerging in the biotech space. Implants like the one developed by the Brigham and Women’s Hospital bring scientists one step closer to better being able to use tools and data to provide more personalized care treatment plans for cancer patients.

Researchers at Northwestern University developed a bioelectric implant that can detect temperature fluctuations that typically happen right before a body rejects an organ transplant. The sensor is smaller than a fingernail, and a mere 220 micrometers thick.

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

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

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

Northwestern University

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

Johnson & Johnson's Medical technology arm received FDA approval for a new workflow that will make it safer for medical professionals to treat atrial fibrillation, a condition that makes your heartbeat irregular and can cause stroke or heart failure. Several products developed by Biosense Webster, which is part of J&J MedTech, got the OK for a "zero fluoroscopy workflow" from the FDA, meaning live X-ray imaging will no longer be needed during catheter insertion procedures. Instead of using X-rays to insert Biosense catheters, medical professionals can now use ultrasound to guide treatments.

Using fewer X-rays, or fluoroscopy, lowers radiation exposure for both patients and medical professionals. Currently, doctors and medical staff who work in treatment rooms that specialize in treating relevant heart procedures often get too much exposure to radiation over time, which can lead to problems like eye issues, cancer, and bone injuries. This FDA approval helps address the recurring occupational hazard. Providers working in cath labs also won't have to wear heavy protective gear like lead aprons anymore when applying the newly approved workflow, reducing the risk of long-term muscle and bone pain.

This move by the FDA marks the first and only approval of its kind. The thumbs up was based on data from clinical trials and research from the REAL AF Registry, or the real-world evidence registry in the electrophysiology field. The data backed how well the treatment works in real-life situations. The new method will only apply for Biosense products like the THERMOCOOL SMARTTOUCH SF catheter, the most commonly used ablation catheter, among others.

“Let’s see what a Snickers bar does to my blood sugar,” Justin Richard, a 52-year-old Toronto-based TikToker says just before eating the candy bar on camera. After an edited time skip, Richard says, “It’s been several hours since I’ve had the chocolate bar, let’s have a look at the glucose monitor and see what actually happened.” He slightly lifts his arm flashing the device, an inconspicuous blue circular patch that almost looks like a Band-Aid. Above his head flashes a screenshot of his blood glucose reading, which appears to have spiked, dipped, and spiked again. “I had a spike in my blood sugar,” he says. “That's not a shock because this is loaded with sugar.” A red ‘X’ graphic appears over some b-roll of the Snickers bar. “I did this test because I’m trying to establish a benchmark.”

This is a typical 60-second TikTok from Richard, whose handle is @insulinresistant1 on the platform. In the following clip, Richard eats a cup of broccoli before eating another full Snickers bar, then goes on to share the results of his blood glucose levels from his personal continuous glucose monitor. He eats this oddball combination to show how variations in his food intake can impact or even prevent a blood glucose spike.

Continuous glucose monitors (or CGMs) have long been used as a tool to track blood sugar levels for people with Type 1 and Type 2 diabetes. Here’s the thing, though: Richard does not have diabetes.

While monitoring sugar intake is standard practice for people on tight blood sugar control treatment plans and those with persistently low blood glucose levels, modern CGM devices – non-invasive wearables that can attach to the back of an arm for weeks at a time – have become a popular wellness trend on social media. Users like Richard that have integrated a CGM into their daily life have stormed platforms like TikTok and Instagram. Some internet health coaches and dieticians have trumpeted their praise. On TikTok, the hashtags #insulinresistance has 1.2 billion views, while #continuousglucosemonitor has over 32.7 million views. Richard, who has over 800,000 TikTok followers, is just one influencer who helped fuel this trend. On his page, which he started during the pandemic, showcases him eating a wide range of foods and drinks, from sodas to chocolate bars, reacting to readings emitting from his Signos-sponsored CGM device.

Richard says he got into continuous glucose monitoring to “optimize his health” and prevent chronic illness, which was especially important to him considering his extensive family history of Type 2 diabetes. “It's like having a coach,” he said in an interview. “But the coach is telling you to do something.” That something was to make some pretty dramatic dietary changes. “'I'm not a healthcare professional and I don't pretend to be. All of my tests are about my blood sugar, and what I read online and how it affects me,” he said, adding that his disclaimer that “individual results will vary” is a key part of his messaging.

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Blood glucose monitoring devices are not new. In the late 1990s, medical companies like Medtronic, Dexcom and Abbott revolutionized the way diabetes could be managed. The importance of continuous glucose monitoring for patients is well established as a means of improving glycemic control, especially in the case of Type 1 diabetes.

CGMs are a vital tool for preventing diabetic ketoacidosis, a life-threatening complication seen in Type 1 diabetic patients. When sugar levels are too high and the body begins to break down fat as fuel, it can lead to a high amount of acid circulation in the bloodstream. For non-diabetics, however, complications stemming from extremely high or low blood sugar levels isn’t a concern. There is little to no research to back that monitoring blood glucose levels in generally healthy adults equates to an overall improvement in health. 

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Dr. Idz, another TikToker with over 1.7 million followers, calls the use of CGM devices for adults without any prescribed medical need a “feature of disordered eating.” Dr. Idz, short for Idrees Mughal, is a board-certified UK-trained medical doctor with expertise in nutritional research. He became a prominent figure when he started rebuking the “nonsense health information” circulating on TikTok that “prey[s] on people's vulnerabilities.” He says CGMs aren’t really intended for non-diabetics because “our body is designed to regulate the spike.” Dr. Idz says people need to understand that spiking blood glucose is not a problem. In fact, that is supposed to happen when you eat food. “Even protein can spike your blood glucose, and no one is really hyped about that, right?”

Although there may not be an inherent physical risk for people who wear a CGM device to monitor and track sugar levels, there is a real possibility that access to “too much data” can lead to information overload, false alarms, unnecessary anxiety, confusion or misinterpretation. Slight fluctuations in blood sugar levels are normal in people who don’t have diabetes. Dr. Robert Shmerling, a senior faculty editor for Harvard Health Publishing and author of “Is blood sugar monitoring without diabetes worthwhile?” writes that, “we're at the very beginning of the learning curve for home monitoring of blood sugar in people without diabetes. Before buying into what may be the next fad in health monitoring, I think we need to learn a lot more.”

Still, it’s no surprise that more people are interested in experimenting with CGM devices. Not only are TikTokers promoting blood glucose monitoring as an indicator of health and wellness, but ads for CGM devices from up-and-coming brands like Nutrisense, Veri and Signos have been flooding social media.

The companies use language designed to sell the average person on the importance of regularly tracking blood sugar levels as a way to lose weight or as a “metabolism hack.” The idea is that eating refined carbs and sugary foods can spike blood glucose levels and, over time, the cells that are supposed to take up insulin and regulate glucose production in the liver become resistant to the hormone due to habitual bad dieting. Heather Davis, a registered and licensed dietitian and nutritionist at Nutrisense denies that the company promises weight loss through glucose monitoring. “A CGM is not a weight loss device per se,” she said. “The CGM is simply one tool among many that may support insights into how different dietary and lifestyle approaches influence metabolic health, including weight factors.”

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Dr. Idz would disagree with Nutrisense on that. He argues that the vast majority of people won't even know how to interpret CGM results. “Even me as a medical doctor, I would probably need to look at some reference values for each individual, you know, perhaps have to do some calculations. And that's me who's actually a medical doctor. Imagine the average person who's just going, ‘oh, my gosh, I've had a spike. That must mean it's bad, right?’ You don't even know how to interpret it. So it's going to be completely useless.”

Nutrisense’s Davis concedes that there is limited research currently looking at CGM use in non-diabetic populations, but she argues that “once upon a time, there was also limited research looking at CGM use in diabetic populations” and that the “risks of wearing a CGM are extremely minimal for most people.” Still, the FDA has never recommended continuous glucose monitoring for healthy individuals. It has only even approved a handful of devices for people who do suffer from diabetes. Although it may be useful for predicting a risk for pre-diabetes and diabetes, there is a consensus that more scientific studies are needed to observe CGM use among healthy populations.

Companies marketing their wearables to healthy people are entering a crowded, but growing market that’s ripe for exploitation. There is arguably an enormous opportunity for companies advertising to healthy individuals to reap financial benefits from the latest health fad.

Signos

TikToker Richard says he thinks continuous glucose monitoring is only going to grow from here. “I don't think this trend is going to end anytime soon,” he said. “Anybody and every country that's adopted this fast food, highly processed diet is having this same increase in Type 2 diabetes and you really can't ignore it. So I think this trend is gonna continue as long as this fast food is so prevalent.” Dr. Idz, on the other hand, would argue that if you want to prevent diabetes, “that's fine but you're not going to do it by wearing a CGM because you know, as long as you're not insulin resistant, you'll find that you don't need you don't need a CGM.”

To make matters worse, not only are CGMs questionably useful for healthy individuals, but they can be expensive, too. The devices must be replaced every seven to 14 days depending on the manufacturer. Nutrisense does not accept insurance coverage on the grounds it is a “wellness program,” with monthly subscriptions starting at $225 and no-commitment plans reaching $399 a month. Competitors like Signos, which accepts insurance with a diabetes diagnosis, offers a monthly plan for its wearable and monitoring app, and that costs upwards of $449 a month. Veri may accept insurance, depending on the provider. And even though it’s able to dramatically undercut its competitors, the monthly fee of between $40 to $109 is hardly cheap. Richard, who has historically paid out of pocket for his CGM devices, believes the high cost is going to “save him money in the long run.”

Unfortunately, these lofty prices don’t just affect health-conscious TikTokers. Access to CGM devices for diabetic populations can be spotty. Individuals covered by Medicaid are less likely to have one covered, especially people of color, according to the American Diabetes Association (ADA).

Aside from the technology’s often inaccessible price points, some experts argue that there simply isn't enough guidance from the scientific community on CGM applications for healthy individuals. The ADA does not recommend CGM device use by healthy people, only clearly stating that the technology should be considered “from the outset of the diagnosis of diabetes that requires insulin management.”

Dr. Idz takes this a step further, stating flatly that “there is no evidence whatsoever that blunting blood sugar spikes does anything for our health.” He backs up his argument with research from a retrospective and randomized trial that focused on the impact of blood glucose monitoring in diabetic and non-diabetic populations. Dr. Idz says, if anything, research suggests that a low average blood glucose level is bad for you and might increase mortality risk over time due to diminished consumption of healthy nutrients and decreased liver function.

Harvard’s Dr. Shmerling reports he could not find a published study suggesting that monitoring blood glucose levels directly translated into improved health. “Unfortunately, some makers of CGM systems aren't waiting for solid research results to market these devices to healthy people. So, consumers and marketing professionals — not researchers or doctors — may wind up driving demand for the product,” Dr. Shmerling writes. Despite the lacking body of evidence to support blood glucose monitoring among healthy populations, the inflated price points for direct to consumer products, and the technological handicaps still present in the burgeoning industry, the growing popularity of CGMs among health and fitness enthusiasts does not seem to be slowing down.

Japanese drugmaker Eisai and US-based Biogen have been working together on advancing research in the space of Alzheimer’s for nearly a decade. Finally, the FDA, granted the fruits of that labor, Leqembi, its blessing for intravenous use. This marks the first approved treatment that can slow the progression of Alzheimer’s.

Leqembi received a preliminary approval in January that allowed it to be used in a limited capacity. That approval was conditioned on the two drug makers conducting a confirmatory study to verify the drug's clinical benefit.

Though Leqembi slows Alzihmer’s progression, it is not a cure. Instead, it addresses the underlying biology that spurs Alzheimer's advancement. The drug works by reducing amyloid plaques, or "misfolded" proteins that form in the brain of a person with Alzheimer's.

Leqembi isn’t the only drug targeting beta-amyloid plaque buildup to treat Alzheimer's. Aduhelm received approval under the accelerated pathway in 2021, but it’s still not fully FDA-approved. But what sets Leqembi apart from its predecessor is that the drug demonstrated actual clinical benefit in addition to simply reducing the buildup of the AD-inducing proteins.

Besides needing a medical prescription, taking the drug will require professional administration in a hospital or infusion center every two weeks. The company, though it may not be its sole responsibility, recognizes its need to boost accessibility. In a public statement, Christopher Viehbacher, the CEO of Biogen, said the company’s main focus now is to work with Eisai to make Leqembi “accessible to eligible patients as soon as possible.”

The drug’s hefty price tag of $26,500 will unfortunately make it inaccessible to most. Current rules mean that it’s unlikely to be covered by Medicare. According to the Alzheimer's Association, those on Medicaid only should be able to get coverage of the FDA-approved drug in most cases. But, even if Medicaid does cover it, patients would be responsible for a 20 percent copay – or about $5,300. Experts predict the total cost of Leqembi treatment can run upward of $90,000 a year, if you take infusions and laboratory tests into account.

An expensive treatment program is something to consider for the one in nine Americans who are over the age of 65 that have Alzheimer’s dementia. That number is expected to grow as the nation’s aging population continues to grow. The number of Americans 65 and older is projected to climb from 58 million in 2021 to 88 million by 2050. This has led to an increased focus on treatments and diagnostics for Alzheimer’s, like blood tests that can detect the disease.

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.

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.

It’s taken longer than we’d hope, but since October, the FDA finally established a framework for new category of hearing aids that don’t need a medical exam, prescription or a fitting by an audiologist. Unsurprisingly we’re seeing the first OTC products being announced at CES. Sennheiser, a mainstay of the consumer audio world, is tossing its proverbial hat into the ring with the Conversation Clear Plus.

As the name suggests, the focus appears to be on dialogue (rather than the holistic hearing experience). Sennheiser says the earbuds will make it easier to understand conversations in noisy environments. This, the company claims, is achieved in a number of ways. At the heart of the device is a Sonova chip. Sonova is behind some of the legacy names in hearing aids such as Phonak and Unitron and it also bought Sennheiser's consumer audio business about 18 months ago.

The Conversation Clear Plus looks a lot like a pair of regular true wireless headphones which will go a long way to removing any stigma or association with conventional hearing aids. Unsurprisingly, they do share a lot of features with regular headphones too. That includes active noise cancellation, even if the application here is more focused on reducing background noise in relation to dialogue.

Sennheiser

Like most wireless headphones you’ll have the option to adjust the amount of noise reduction and there’s a companion app for further tuning your hearing experience. Sennheiser says there are three main prestets: Relax, Communication and Streaming. Those are all fairly self explanatory, but the last one marks a key difference between this category and legacy hearing aids — the ability to stream music and audio from your phone. Some hearing aids can do this, but it’s often a sub-optimal experience given that it’s not what they were primarily designed for. Given Sennheiser’s credentials in the headphone world, it seems likely streaming will be comparable to its consumer headphones.

On a more practical note, the Conversation Clear Plus offers a nine hour battery life per charge, with an additional 27 hours/three charges available via the case.

One of the big promises with OTC hearing aids was a significant reduction in cost. Typically a set with a fitting from an audiologist would cost several thousand dollars, the Conversation Clear Plus will retail for $850. The experiences between the two different product categories will obviously be somewhat distinct, given the different form factor, but the modern, gadgety design will appeal to a lot of folks that might otherwise be turned off by the clinical design of classic hearing aids.

The Conversation Clear Plus will be available for pre-order starting Jan 5 and will go on general sale Jan 20.

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.

Adults in the US with mild-to-moderate hearing loss can now buy hearing aids online or from a store without a prescription, medical exam or audiologist fitting. The Food and Drug Administration issued a final rule in August that allows stores and online retailers to sell over-the-counter (OTC) devices starting today.

The move could save consumers thousands of dollars on a pair of hearing aids, according to the White House. Walmart is now selling them through its website, Sam's Club, more than 1,000 in-store Vision Centers and 474 Sam’s Club Hearing Aid Center locations. Walmart's options cost between $199 and $999 per pair. The company claimed comparable prescription hearing aids cost between $4,400 and $5,500.

Walgreens and CVS are also now selling OTC hearing aids. Best Buy and Hy-Vee will begin selling them online this week and in stores a little later.

Last week, Sony announced two hearing aid models that it created with WS Audiology. The CRE-C10 has a battery life of up to 70 hours on a single charge, according to Sony. That model will be available sometime this month. The CRE-E10, meanwhile, will cost $1,300. Sony claims it has a battery life of 26 hours, though you'll be able to recharge it wirelessly. The CRE-E10 can also connect to an iPhone for audio playback.

Jabra revealed a set of hearing enhancement earbuds in August 2021. While they were initially available from hearing care clinics, but Jabra says they're now on sale as OTC hearing aids. Early last year, Bose announced what it claimed were the first FDA-cleared hearing aids that don't need a prescription or visit to a doctor.

Nearly 30 million Americans are believed to have some degree of hearing loss, including 10 million folks under the age of 60. Over-the-counter hearing aids could drastically improve many people's quality of life, especially since the devices should be far less expensive. However, those who have severe hearing loss or anyone aged under 18 will still need a prescription for hearing aids, the FDA ruled.