Dr. Tom Oxley visibly stiffens at the prospect of using brain-computer interface technology for something as gauche as augmenting able-bodied humans. “We're not building a BCI to control Spotify or to watch Netflix,” the CEO of medical device startup Synchron tersely told Engadget via videocall last week.

“There's all this hype and excitement about BCI, about where it might go,” Oxley continued. “But the reality is, what's it gonna do for patients? We describe this problem for patients, not around wanting to super-augment their brain or body, but wanting to restore the fundamental agency and autonomy that [able-bodied people] take for granted.”

Around 31,000 Americans currently live with Amyotrophic lateral sclerosis (ALS) with another 5,000 diagnosed every year. Nearly 300,000 Americans suffer from spinal cord paralysis, and another approximately 18,000 people join those ranks annually. Thousands more are paralyzed by stroke and accident, losing their ability to see, hear or feel the world around them. And with the lack of motor control in their extremities, these Americans can also lose access to a critical component of modern life: their smartphone.

“[A smartphone] creates our independence and our autonomy,” Oxley said. “It's communicating to each other, text messaging, emailing. It's controlling the lights in your house, doing your banking, doing your shopping, all those things.”

“If you can control your phone again,” he said. “you can restore those elements of your lifestyle.”

So while Elon Musk promises an fantastical cyberpunk future where everybody knows Kung Fu and can upload their consciousness to the cloud on a whim, startups like Synchron, as well as Medtronic, Blackrock Neurotech, BrainGate and Precision Neuroscience and countless academic research teams, are working to put this transformative medical technology into clinical practice, reliably and ethically.

The Best Way to a Man’s Mind Is Through His Jugular Vein

Brooklyn-based Synchron made history in 2022 when it became the first company to successfully implant a BCI into a human patient as part of its pioneering SWITCH study performed in partnership with Mount Sinai Hospital. To date, the medical community has generally had just two options in capturing the myriad electrical signals that our brains produce: low-fidelity but non-invasive EEG wave caps, or high-fidelity Utah Array neural probes that require open-brain surgery to install.

Synchron’s Stentrode device provides a third: it is surgically guided up through a patient’s jugular vein to rest within a large blood vessel near their motor cortex where its integrated array of sensors yield better-fidelity signal than an EEG cap without the messy implantation or eventual performance drop off of probe arrays.

“We're not putting penetrative electronics into the brain and so the surgical procedure itself is minimally invasive,” Dr. David Putrino, Director of Rehabilitation Innovation for the Mount Sinai Health System, explained to Engadget. “The second piece of it is, you're not asking a neurologist to learn anything new ... They know how to place stents, and you're really asking to place a stent in a big vessel — it's not a hard task.”

“These types of vascular surgeries in the brain are commonly performed,” said Dr. Zoran Nenadić, William J. Link Chair and Professor of Biomedical Engineering at the University of California, Irvine. “I think they're clever using this route to deliver these implants into the human brain, which otherwise is an invasive surgery.”

Though the Stentrode’s signal quality is not quite on par with a probe array, it doesn’t suffer the signal degradation that arrays do. Quite the opposite, in fact. “When you use penetrative electrodes and you put them in the brain,” Putrino said, “gliosis forms around the electrodes and impedances change, signal quality goes down, you lose certain electrodes. In this case, as the electrode vascularizes into the blood vessel, it actually stabilizes and improves the recording over time.”

A Device for Those Silent Moments of Terror

“We're finally, actually, paying attention to a subset of individuals with disabilities who previously have not had technology available that gives them digital autonomy,” Putrino said. He points out that for many severely paralyzed people, folks who can perhaps wiggle a finger or toe, or who can use eye tracking technology, the communication devices at their disposal are situational at best. Alert buttons can shift out of reach, eye tracking systems are largely stationary tools and unusable in cars.

“We communicate with these folks on a regular basis and the fears that are brought up that this technology can help with,” Putrino recalls. “It is exactly in these silent moments, where it's like, the eye tracking has been put away for the night and then you start to choke, how do you call someone in? Your call button or your communication device is pushed to the side and you see the nurse starting to prepare the wrong medication for you. How do you alert them? These moments happen often in a disabled person's life and we don't have an answer for these things.”

With a BCI, he continued, locked-in patients are no longer isolated. They can simply wake their digital device from sleep mode and use it to alert caregivers. ”This thing works outside, it works in different light settings, it works regardless of whether you're laying flat on your back or sitting up in your chair,” Putrino said. “Versatile, continuous digital control is the goal.”

Reaching that goal is still at least half a decade away. “Our goal over the next five years is to get market approval and then we’ll be ready to scale up that point,” Oxley said. The rate of that scaling will depend on the company’s access to cath labs. These are facilities found in both primary and secondary level hospitals so there are thousands of them around the country, Oxley said. Far more than the handful of primary level hospitals that are equipped to handle open-brain BCI implantation surgeries.

A Show of Hands for Another Hole in Your Head

In 2021, Synchron conducted its SWITCH safety study for the Stentrode device itself, implanting it in four ALS patients and monitoring their health over the course of the next year. The study found the device to be “safe, with no serious adverse events that led to disability or death,” according to a 2022 press release. The Stentrod “stayed in place for all four patients and the blood vessel in which the device was implanted remained open.”

Buoyed by that success, Synchon launched its headline-grabbing COMMAND study last year, which uses the company’s entire brain.io system in six patients to help them communicate digitally. “We’re really trying to show that this thing improves quality of life and improves agency of the individual,” Putrino said. The team had initially expected the recruitment process through which candidate patients are screened, to take five full years to complete.

Dr. Putrino was not prepared for the outpouring of interest, especially given the permanent nature of these tests and quality of life that patients might expect to have once they're in. “Many of our patients have end-stage ALS, so being part of a trial is a non-trivial decision,” Putrino said. “That's like, do you want to spend what maybe some of the last years of your life with researchers as opposed to with family members?”

“Is that a choice you want to make for folks who are considering the trial who have a spinal cord injury?” asked Putrino, as those folks are also eligible for implantation. “We have very candid conversations with them around, look, this is a gen one device,” he warns. “Do you want to wait for gen five because you don't have a short life expectancy, you could live another 30 years. This is a permanent implant.”

Still, the public interest in Synchron’s BCI work has led to such a glut of interested patients, that the team was able to perform its implantation surgery on the sixth and final patient of the study in early August — nearly 18 months ahead of schedule. The team will need to continue the study for at least another year (to meet minimum safety standards like in the previous SWITCH study) but has already gotten permission from the NIH to extend its observation portion to the full original five years. This will give Synchron significantly more data to work with in the future, Putrino explained.

How We Can Avoid Another Argus II SNAFU

Our Geordi LaForge visor future seemed a veritable lock in 2013, when Second Sight Medical Products received an FDA Humanitarian Use Device designation for its Argus II retinal prosthesis, two years after it received commercial clearance in Europe. The medical device, designed to restore at least rudimentary functional vision to people suffering profound vision loss from retinitis pigmentosa, was implanted in the patient’s retina and converted digital video signals it received from an external, glasses-mounted camera into the analog electrical impulses that the brain can comprehend — effectively bypassing the diseased portions of the patient’s ocular system.

With the technical blessing of the FDA in hand (Humanitarian Use cases are not subject to nearly the same scrutiny as full FDA approval), Second Sight filed for IPO in 2013 and was listed in NASDAQ the following year. Seven years after that, the company went belly up in 2020, declared itself out of business and wished the best of luck to the suckers who spent $150k to get its hardware hardwired into their skulls.

“Once you're in that [Humanitarian Use] category, it's kind of hard to go back and do all of the studies that are necessary to get the traditional FDA approvals to move forward,” Dr. An Do, Assistant Professor in the Department of Neurology at University of California, Irvine, told Engadget. “I think the other issue is that these are orphan diseases. There's a very small group of people that they're catering to.”

As IEEE Spectrum rightfully points out, one loose wire, one degraded connection or faulty lead, and these patients can potentially re-lose what little sight they had regained. There’s also the chance that the implant, without regular upkeep, eventually causes an infection or interferes with other medical procedures, requiring a costly, invasive surgery to remove.

“I am constantly concerned about this,” Putrino admitted. “This is a question that keeps me up at night. I think that, obviously, we need to make sure that companies can in good faith proceed to the next stage of their work as a company before they begin any clinical trials.”

He also calls on the FDA to expand its evaluations of BCI companies to potentially include examining the applicant’s ongoing financial stability. “I think that this is definitely a consideration that we need to think about because we don't want to implant patients and then have them just lose this technology.”

“We always talk to our patients as we're recruiting them about the fact that this is a permanent implant,” Putrino continued. “We make a commitment to them that they can always come to us for device related questions, even outside the scope of the clinical trial.”

But Putrino admits that even with the best intentions, companies simply cannot guarantee their customers of continued commercial success. “I don't really know how we safeguard against the complete failure of a company,” he said. “This is just one of the risks that people are going to take coming in. It's a complex issue and it's one I worry about because we're right here on the bleeding edge and it's unclear if we have good answers to this once the technology goes beyond clinical trials.”

Luckily, the FDA does. As one agency official explained to Engadget, “the FDA’s decisions are intended to be patient-centric with the health and safety of device users as our highest priority.” Should a company go under, file bankruptcy or otherwise be unable to provide the services it previously sold, in addition to potentially being ordered by the court to continue care for its existing patients, “the FDA may also take steps to protect patients in these circumstances. For example, the FDA may communicate to the public, recommendations for actions that health care providers and patients should take.”

The FDA official also notes that the evaluation process itself involves establishing whether an applicant “demonstrates reasonable assurance of safety and effectiveness of the device when used as intended in its environment of use for its expected life … FDA requirements apply to devices regardless of a firm’s decision to stop selling and distributing the device.”

The Synchron Switch BCI, for its part, is made from biologically inert materials that will eventually be reabsorbed into the body, “so even if Synchron disappeared tomorrow, the Switch BCI is designed to safely remain in the patient’s body indefinitely,” Oxley said. “The BCI runs on a software platform that is designed for stability and independent use, so patients can use the platform without our direct involvement.”

However, this approach “is not sufficient and that, given BCIs’ potential influence on individuals and society, the nature of what is safe and effective and the balance between risk and benefit require special consideration,” argued a 2021 op-ed in the AMA Journal of Ethics. “The line between therapy and enhancement for BCIs is difficult to draw precisely. Therapeutic devices function to correct or compensate for some disease state, thereby restoring one to ‘normality’ or the standard species-typical form.” But what, and more importantly who, gets to define normality? How far below the mean IQ can you get before forcibly raising your score through BCI implantation is deemed worthwhile to society?

The op-ed’s authors concede that “While BCIs raise multiple ethical concerns, such as how to define personhood, respect for autonomy, and adequacy of informed consent, not all ethical issues justifiably form the basis of government regulation.” The FDA’s job is to test devices for safety and efficacy, not equality, after all. As such the authors instead argue that, “a new committee or regulatory body with humanistic aims, including the concerns of both individuals and society, ought to be legislated at the federal level in order to assist in regulating the nature, scope, and use of these devices.”

The Withings Body Scan Connected Health Station has received the go-ahead from the FDA and is set to launch this fall. Engadget’s Daniel Cooper tried it earlier this year and had “nothing but praise for” the luxury smart scale when trying it earlier this year, although he also described its $400 price tag as “mad money” to pay for an extravagance many of us won’t need.

The Body Scan was announced back at CES 2022, seemingly another epoch in the fast-moving world of consumer tech. Withings initially priced the scale at $300, but after getting caught in FDA approval limbo — and facing inflation and a semiconductor crisis during that window — its cost grew.

As for what you get for that significant investment, the scale is a powerhouse. It’s the first FDA-approved health station that detects atrial fibrillation through a six-lead ECG. In addition, it analyzes your segmented body composition, measures nerve activity and monitors your vascular age. It even uses Galvanic Skin Response (GSR) to monitor foot sweat levels to screen for signs of neuropathy.

During Engadget’s time with it, we found the process to be straightforward and nearly effortless. “Get on the scale, hold the grab at pelvis height and wait 90 seconds for it to do its thang,” Daniel Cooper wrote in February. “It’ll run the gamut of tests measuring your weight, body fat, muscle mass, visceral fat, ECG, Pulse Wave Velocity, vascular age and nerve health. It’ll then relay those data points to you in a big, bright, bold and easy-to-read manner, followed by the day’s weather and an indicator about the local air quality (pulled from an online service).”

The device itself consists of a tempered glass platform with an integrated retractable handle. It has four weight sensors, 14 ITP electrodes on the scale and four stainless steel electrodes in the handle. Withings says its battery will last 12 months before needing a recharge. The device’s display is a 3.2-inch color LCD for viewing your metrics. Withings says the scale’s weight measurements are precise down to 0.1 lbs. It measures Basal Metabolic Rate (BMR).

The Withings Body Scan Connected Health Station will be available this September for $400. 

CVS Health is launching a new subsidiary unit, Cordavis, that will collaborate with drug manufacturers to produce biosimilar products, or medications that are near identical to an already approved and existing drug. This unit will commercialize and co-produce FDA-approved biosimilar products to U.S. markets, which will likely have a trickle-down effect on the way consumers buy drugs by increasing competition and driving down prices.

This subsidiary will not reinvent the wheel with new drugs. All the biosimilar products produced will be highly similar to an already approved biologic medicine but will still undergo testing and approvals to ensure they are highly comparable in terms of safety, efficacy and quality. If generic drugs are the Kirkland brand of medication — an identical product made cheaper through the expiration of a patent — biosimilars are more like Amazon Basics: less expensive, legally distinct but functionally the same as what they imitate. CVS claims that Cordavis will "help ensure consistent long-term supply of affordable biosimilars" when it officially debuts at the beginning of 2024.

The first confirmed offering from Cordavis in the near future is Hyrimo, a biosimilar of the drug Humira. Humira is an injectable drug that is used to treat a range of diseases, including Crohn's and rheumatoid arthritis in adults. The drug is a popular prescription that generated its maker AbbVie net revenues of $3.5 billion in global sales in the second quarter of 2023. It has a list price of nearly $7,000 a month, making it a prime drug worth diluting in the competitive pharmaceutical landscape. Cordavis says its biosimilar for Humira will list under a new private label and will be 80 percent cheaper than the current list price of the drug. This early offering gives just a snapshot of the kind of influence Cordavis can have on disruption in the drug manufacturing space.

The internet is a source of many things, such as yummy recipes, tech deals and horrible misinformation. The latter often spreads through social media sites, something they have to combat (or usually choose to ignore). Right now, YouTube is choosing to fight, announcing a new long-term policy plan to grapple with medical misinformation, especially about cancer.

YouTube's new guidelines for health content will fall under three categories: prevent, treatment and denial misinformation. Prevent will allegedly review and remove videos that oppose guidelines set out by trusted authorities or contradict vaccine safety and efficacy (the platform banned content with vaccine misinformation in 2021). Treatment should center on taking down any misinformation about — unsurprisingly — treating medical conditions, including unproven remedies. The platform claims that denial will focus on removing any content that makes a false claim, such as that people didn't die due to COVID-19.

"To determine if a condition, treatment or substance is in scope of our medical misinformation policies, we'll evaluate whether it's associated with a high public health risk, publicly available guidance from health authorities around the world, and whether it's generally prone to misinformation," YouTube's Director and Global Head of Healthcare and Public Health Partnerships Dr. Garth Graham and its VP and Global Head of Trust and Safety Matt Halprin said in the joint release outlining the new policies.

Starting now, YouTube says it will be removing videos specifically about cancer which violate any of these policies — an effort it claims will ramp up more in the coming weeks. For example, if a video states that garlic cures cancer, it's coming down. YouTube is also sharing a playlist of science-backed cancer-related videos and teaming up with Mayo Clinic to create even more informational videos about cancer.

These policies come less than two months after YouTube announced it would "stop removing content that advances false claims that widespread fraud, errors, or glitches occurred in the 2020 and other past US Presidential elections" because it curtailed political speech. So misinformation is allowed when it threatens democracy, just not across every category on the site — cool. Though, YouTube does say that it will allow some health videos with falsehoods to remain if the context is right, such as public interest. The platform says in some cases, content will be allowed to stay up but will be given an age restriction.

Biogen and Sage Therapeutics' collaboration to develop Zurzuvae has proved fruitful. The FDA approved the oral pill specifically for the treatment of postpartum depression (PPD), making it the first of its kind in a class of antidepressants intended specifically for new mothers. According to research by the CDC, one in eight women will experience symptoms of postpartum depression. Symptoms of PPD can occur quite intensely after birth and can be dangerous because it can interfere with a new mother’s ability to function. The long-awaited approval comes thanks to two randomized, double-blind studies that proved the efficacy of the drug.

A key hallmark of Zurzuvae is that the medication is expected to work within just a few days and is meant to be taken for up to two weeks. Before this once-daily oral pilll, the most common treatment plan for PPD required an IV injection. That meant administration by a healthcare provider in a hospital or healthcare facility was necessary. With this approval, Zurzuvae will be able to expand access and reach to more women on their way out of hospitals.

The catch is the drug can impact a patient's ability to drive and cause extreme drowsiness. Additionally, the warning label for the drug highlights that, like most antidepressants, the drug can cause an increased risk for suicidal ideation. To top it off, Zurzuvae may also cause fetal harm. Patients on the drug should use contraception while taking the pill and for one week after taking Zurzuvae.

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.

A newly published study in the the Lancet Oncology journal has found that the use of AI in mammogram cancer screening can safely cut radiologist workloads nearly in half without risk of increasing false-positive results. In effect, the study found that the AI’s recommendations were on par with those of two radiologists working together.

“AI-supported mammography screening resulted in a similar cancer detection rate compared with standard double reading, with a substantially lower screen-reading workload, indicating that the use of AI in mammography screening is safe,” the study found.

The study was performed by a research team out of Lund University in Sweden and, accordingly, followed 80,033 Swedish women (average age of 54) for just over a year in 2021-2022 . Of the 39,996 patients that were randomly assigned AI-empowered breast cancer screenings, 28 percent or 244 tests returned screen-detected cancers. Of the other 40,024 patients that received conventional cancer screenings, just 25 percent, or 203 tests, returned screen-detected cancers.

Of those extra 41 cancers detected by the AI side, 19 turned out to be invasive. Both the AI-empowered and conventional screenings ran a 1.5 percent false positive rate. Most impressively, radiologists on the the AI side had to look at 36,886 fewer screen readings than their counterparts, a 44 percent reduction in their workload.

“These promising interim safety results should be used to inform new trials and program-based evaluations to address the pronounced radiologist shortage in many countries, but they are not enough on their own to confirm that AI is ready to be implemented in mammography screening," lead author, Dr Kristina Lång, warned in a release. “We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology.”

Cancer detection has been an aspirational goal for computer vision researchers and AI companies for years now. I mean, who doesn’t want to be the company to build the tricorder that infallibly spots cancerous growths in their earliest stages? Machine vision systems designed for these screenings have improved steadily in recent years and in specific cases have shown to be as reliable as human clinicians, with the likes of IBM, Google, MIT and NVIDIA investing in similar cancer screening research in recent years.

Keith Thomas from New York was involved in a driving accident back in 2020 that injured his spine's C4 and C5 vertebrae, leading to a total loss in feeling and movement from the chest down. Recently, though, Thomas had been able to move his arm at will and feel his sister hold his hand, thanks to the AI brain implant technology developed by the Northwell Health's Feinstein Institute of Bioelectronic Medicine. 

The research team first spent months mapping his brain with MRIs to pinpoint the exact parts of his brain responsible for arm movements and the sense of touch in his hands. Then, four months ago, surgeons performed a 15-hour procedure to implant microchips into his brain — Thomas was even awake for some parts so he could tell them what sensations he was feeling in his hand as they probed parts of the organ. 

While the microchips are inside his body, the team also installed external ports on top of his head. Those ports connect to a computer with the artificial intelligence (AI) algorithms that the team developed to interpret his thoughts and turn them into action. The researchers call this approach "thought-driven therapy," because it all starts with the patient's intentions. If he thinks of wanting to move his hand, for instance, his brain implant sends signals to the computer, which then sends signals to the electrode patches on his spine and hand muscles in order to stimulate movement. They attached sensors to his fingertips and palms, as well, to stimulate sensation. 

Thanks to this system, he was able to move his arm at will and feel his sister holding his hand in the lab. While he needed to be attached to the computer for those milestones, the researchers say Thomas has shown signs of recovery even when the system is off. His arm strength has apparently "more than doubled" since the study began, and his forearm and wrist could now feel some new sensations. If all goes well, the team's thought-driven therapy could help him regain more of his sense of touch and mobility. 

While the approach has a ways to go, the team behind it is hopeful that it could change the lives of people living with paralysis. Chad Bouton, the technology's developer and the principal investigator of the clinical trial, said:

"This is the first time the brain, body and spinal cord have been linked together electronically in a paralyzed human to restore lasting movement and sensation. When the study participant thinks about moving his arm or hand, we ‘supercharge’ his spinal cord and stimulate his brain and muscles to help rebuild connections, provide sensory feedback, and promote recovery. This type of thought-driven therapy is a game-changer. Our goal is to use this technology one day to give people living with paralysis the ability to live fuller, more independent lives."

GoodRx, best known for its prescription drug price comparison tool, has launched a new free offering called “Medicine Cabinet.” The tool will allow GoodRx app users to manage their prescription medications on a single platform. This comes on the heels of the news that the company is working with CVS Health to develop the Caremark Cost Saver, which could lower pharmacy out-of-pocket drug costs for shoppers.

Medicine Cabinet will automatically integrate within the GoodRx app and will feature tools like a “prescriptions dashboard” where a consumer can set up refill reminders and find the best pharmacies to pick up their medications at the lowest price. At the heart of the app are daily pill reminders that are customizable to any treatment plan that is uploaded into the app. GoodRx Chief Product Officer Mark Hull said the reminders feature is huge because 50 percent of the time, Americans are struggling to take their medications as prescribed for reasons as simple as forgetfulness or cost.

The Medicine Cabinet also includes a dashboard for GoodRx’s rewards program which offers users monetary perks like e-gift cards for staying on top of medication refills. “Nobody's integrating or rewarding people for having those healthy habits,” Hull said.

“What we've found is that the winning model for us is to marry the discounts, the value and the rewards, with the basic healthy habits and reminder stuff,” he added. GoodRx claims it can save consumers up to 80 percent off the price of prescription drugs by partnering with pharmacy benefits managers to negotiate deals on drugs. Normally, the average consumer wouldn’t otherwise have access to these discounts without middlemen like GoodRx.

GoodRx

The Medicine Cabinet tool has only been in development for roughly six months and will be available on iOS, but not on Android just yet.

“GoodRx was able to develop Medicine Cabinet so quickly in part due to the data it has already amassed from users and providers over the last decade.” "If a startup were doing this, it would take a long time, they don't have the data, they don't have the relationships with retailers, they don't already have the customer base," Hull said. “We already have a half a billion prescriptions in federal records from the millions of people who have been using us for the last 12 plus years.”

Hull said he actually wishes Medicine Cabinet could have come sooner. He recalls when his stepfather had a heart attack a couple of years ago. "When he came home from the hospital, he had like a dozen medications he had to manage," Hull said, remembering it as a nerve wracking time for his family and specifically his mother. "For the average person who's managing a condition with multiple medications, it's a lot of work and so we're really trying to make it simple, clear and obvious what you need to do at any given point to help manage your condition."

GoodRx

Down the line, Hull hopes Medicine Cabinet will be easier for older people to use, with the inclusion of features that will let a user take a photo of a medication instead of having to look it up in the database.

Still, GoodRx's history of being caught up in legal trouble related to data privacy issues is worth noting. Earlier this year, the Federal Trade Commission fined the company for the unauthorized disclosure of customers' identifiable health information with third parties, such as Facebook and Google. “Our privacy policy applies to Medicine Cabinet, which sits within the GoodRx app. We are very transparent about what information we collect and how we use it to personalize and customize our products for consumers. Additionally, the feature is only available for users who have registered for a GoodRx account,” a representative said. The company’s recent focus on transparency and adherence to privacy policies suggest it's taking the issue seriously, though as with any telehealth company, data privacy will always be a front and center concern.

“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.